Gefitinib Tablets 250mg

Product Description

---

The tablets contain the active substance gefitinib which blocks a protein called ‘epidermal growth factor receptor’ (EGFR). This protein is involved in the growth and spread of cancer cells.

Gefitinib is used to treat adults with non-small cell lung cancer. This cancer is a disease in which malignant (cancer) cells form in the tissues of the lung.
The tablets contain the active substance gefitinib which blocks a protein called ‘epidermal growth factor receptor’ (EGFR). This protein is involved in the growth and spread of cancer cells.
Gefitinib is used to treat adults with non-small cell lung cancer. This cancer is a disease in which malignant (cancer) cells form in the tissues of the lung.

http://www.tajaccura.com/product/gefitinib-tablets-250mg/

---

WHAT GEFITINIB IS AND WHAT IT IS USED FOR

The tablets contain the active substance gefitinib which blocks a protein called ‘epidermal growth factor receptor’ (EGFR). This protein is involved in the growth and spread of cancer cells.
Gefitinib is used to treat adults with non-small cell lung cancer. This cancer is a disease in which malignant (cancer) cells form in the tissues of the lung.

---

WHAT YOU NEED TO KNOW BEFORE YOU TAKE GEFITINIB

Do not take Gefitinib
• If you are allergic to gefitinib or any of the other ingredients of this medicine (listed in section 6, ‘What Gefitinib contains’).
• If you are breast-feeding.

Warnings and precautions
• Check with your doctor or pharmacist before taking Gefitinib.
• If you have ever had any other lung problems. Some lung problems may get worse during treatment with Gefitinib.
• If you have ever had problems with your liver.
Children and adolescents
• Gefitinib is not indicated in children and adolescents under 18 years.

---

HOW TO TAKE GEFITINIB

• Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• The recommended dose is one 250 mg tablet per day.
• Take the tablet at about the same time each day.
• You can take the tablet with or without food.
• Do not take antacids (to reduce the acid level of your stomach) 2 hours before or 1 hour after taking Gefitinib.
• If you have trouble swallowing the tablet, dissolve it in half a glass of still (non-fizzy) water. Do not use any other liquids. Do not crush the tablet. Swirl the water until the tablet has dissolved. This may take up to 20 minutes. Drink the liquid straight away. To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it.

---

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you notice any of the following side effects – you may need urgent medical treatment:
• Allergic reaction (uncommon), particularly if symptoms include swollen face, tongue or throat, difficulty to swallow, hives and difficulties to breathe.
• Serious breathlessness, or sudden worsening breathlessness, possibly with a cough or fever. This may mean that you have an inflammation of the lungs called ‘interstitial lung disease’. This may affect about 1 in 100 patients taking Gefitinib and can be life-threatening.
• Severe skin reactions (rare) affecting large areas of your body. The signs may include redness, pain, ulcers, blisters, and shedding of the skin. The lips, nose, eyes and genitals may also be affected.
• Dehydration (common) caused by long term or severe diarrhoea, vomiting (being sick), nausea (feeling sick) or loss of appetite.
• Eye problems (uncommon), such as pain, redness, watery eyes, light sensitivity, changes in vision or ingrowing eyelashes. This may mean that you have an ulcer on the surface of the eye (cornea).

---

HOW TO STORE GEFITINIB

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton, blister and overwrap foil after EXP. The expiry date refers to the last day of that month.
• Store in the original package in order to protect from moisture.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Etoposide soft gelatin capsules

Product Description

---

Each capsule contains Etoposide (either 50 or 100mg) as the active ingredient.
Etoposide belongs to the group of medicines called anti-neoplastic agents which are used in the treatment of cancer.

http://www.tajaccura.com/product/etoposide-soft-gelatin-capsules/ 

WHAT ETOPOSIDE IS AND WHAT IT IS USED FOR

The name of this medicine is Etoposide. Each capsule contains Etoposide (either 50 or 100mg) as the active ingredient.
Etoposide belongs to the group of medicines called anti-neoplastic agents which are used in the treatment of cancer.
Etoposide is used in the treatment of certain types of cancer, in particular small cell lung cancer and testicular cancer.
The exact reason why you have been prescribed Etoposide Capsules is best discussed with your doctor.

---

BEFORE TAKING YOUR MEDICINE

DO NOT take Etoposide if:
• you suffer from severe liver problems
• you have had an allergic reaction to a similar medicine or any of the ingredients in this medicine
• you are pregnant or planning to become pregnant or there is any possibility that you could become pregnant
• you are breast feeding
• you have any infections in any area of your body that your doctor does not know about
If any of the above affects you, or if you are unsure if they do, tell your doctor who will be able to advise you.

---

POSSIBLE SIDE EFFECTS

As with all medicines, Etoposide can cause unwanted side effects, although not everybody gets them.
STOP taking the medicine and tell your doctor immediately if you get any of the following symptoms:
• swelling of your tongue or throat, breathing difficulties, fast heartbeat, flushing of the skin or a rash. These may be signs of an allergic reaction.
Possible side effects experienced with Etoposide are;
• blood disorders (this is why you will be having blood tests between courses of treatment)
• temporary hair loss
• nausea and vomiting
• abdominal pain
• loss of appetite
• diarrhoea
• acid reflux
• difficulty swallowing
• high or low blood pressure
• skin problems such as itching, rash and pigmentation
• flushing
• sore mouth
• after taste
• fever
• sleepiness or tiredness
• tingling or numbness in hands and feet
• breathing problems
• temporary blindness

---

HOW TO STORE YOUR MEDICINE

• Keep your medicines out of the reach and sight of children.
• Do not store Etoposide capsules above 25°C
• Etoposide capsules should not get too hot or damp; so do not leave your capsules near a radiator, on a window sill or in the bathroom.
• Please check the expiry date of the product, shown on the blister strip and the outer packaging after EXP. The expiry date refers to the last day of that month. Do not use after the month stated.
• Do not open any blister in which there is evidence of capsule leakage.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

---

---

WHAT ETOPOSIDE CONTAINS

Each soft capsule contains etoposide (either 50mg or 100mg) as the active ingredient.
Etoposide capsules contain the following
Inactive ingredients:
• citric acid,
• glycerol,
• macrogol 400 and water;
Capsules Containing:
• gelatin,
• glycerol, iron oxide (E172),
• sodium hydroxybenzoic acid ethyl ester,
• sodium propyl parahydroxybenzoate (E217),
titanium dioxide (E171) and water.

---

WHAT ETOPOSIDE LOOKS LIKE AND CONTENTS OF THE PACK

Etoposide capsules are opaque pink, soft gelatin capsules.
The 50mg capsules are packed in cartons of 20 capsules and the 100mg capsules are packed in cartons of 10 capsules.

---

Cisplatin injection, a Platinum-containing anti-cancer drug

Cisplatin, also referred to chemically as cis-diamminechloroplatinum, is a member of the therapeutic category of medicines known as Cytotoxic medicines and is more specifically referred to as a Alkylating agent and is commonly used in chemotherapy for the treatment of several different types of cancer. http://www.tajaccura.com/product/cisplatin-injection-bp-10mg/

Cisplatin was the very first member of the class of medicines now referred to as Platinum-containing anti-cancer drugs[1]. Cisplatin has since been joined in this class by Carboplatin and Oxaliplatin. Cisplatin along with the other members of this class act as Platinum complexes which react in vivo to bind to DNA resulting in crosslinking of DNA and triggering programmed cell death
Cisplatin injections are available from Taj Accura Pharmaceuticals in dosages of 10, 50 and 100 mg.

What is Cisplatin used for?
Cisplatin injection, as an alkylating agent, is utilised either as a mono-therapy or a poly-therapy in the treatment of a number of different types of cancer including[2]:

• Cancer of the Bladder
• Cancer of the Testicles
• Cancer of the Ovaries
• Cancer of the Cervix
• Cancer of the Lung

By interfering with cancer cell growth and causing apoptosis, Cisplatin can kill cancer cells in tumours and is considered a very useful chemotherapeutic medicine in the treatment of these cancers. It is most commonly utilised in combination with other medicines when treating cancers which are likely to spread to other parts of the body.
Cisplatin interferes with cancer cell growth but can also affect the growth of normal body cells causing potential for side effects which should be reported to a doctor

How does Cisplatin work?
Cisplatin has been successfully used in chemotherapy regimens for over 35 years but its precise biochemical mechanism of action still has not been fully elucidated[3] (3).
The most commonly accepted mechanism however is that it possesses its cytotoxic effect as a result of binding to the nuclear DNA of cancerous cells and interfering with normal transcription and/or mechanisms need for the replication of DNA. The Cisplatin-DNA adducts are not processed efficiently by the machinery inside the cell eventually leading to cell death

Are there any side effects associated with the use of Methotrexate?
Yes, as with all medication there is a possibility that the patient may experience side effects but not everyone experiences them. Patients are advised to contact their doctor, pharmacist or nurse if they have any questions regarding treatment with Cisplatin.
Cisplatin is a very toxic medicine and is capable of causing serious illness or even death so any side effects experienced should be reported to a doctor. Some of these side effects include allergic symptoms such as flushing, wheezing, rash, swelling of the face, reduced blood pressure and increased heart rate.

How is Cisplatin Injection given?
Cisplatin injections are administered intravenously (into a vein) under strict direction of hospital specialists. Cisplatin in powder form is dissolved to form a solution. The resulting solution is then added to either a salt solution or alternatively a salt and sugar solution which is given into the blood stream over a set amount of time, usually over 6 to 8 hours.
The dose administered is dependent on the body surface area of the patient’s body and the type of cancer being treated. The patient receives 1 to 2 litres of fluid via infusion between 8 and 12 hours before Cisplatin is administered in order to increase the production and passing of urine. This is in order maintain diuresis for 24 hours after the Cisplatin is received.

Conclusion
Cisplatin Injections, for the treatment of testicular, cervical, ovarian, lung and bladder cancer, are available from Taj Accura Pharmaceuticals at strengths of 10, 50 and 100 mg. Always remember to consult your Doctor or Healthcare Professional if you have any questions about your own health or medications.
Always remember to consult your Doctor or Healthcare Professional if you have any questions about your own health or medications.
Taj Accura Pharmaceuticals are committed to providing affordable pharmaceutical care solutions to health providers and patients globally. Our enthusiastic and highly skilled bi-lingual sales team in English and French are more than welcome to take your queries. We are contactable by emailing info@tajaccura, by phone at + 353 (1) 293 1882 or alternatively by fax at + 353 (1) 293 1883

[1] MG Apps EC, NJ Wheate. The state-of-play and future of platinum drugs. Endocr Relat Cancer. 2015;22(4):219-33.
[2] MayoClinic. Cisplatin (Intravenous Route) Mayo Foundation for Medical Education and Research2015
[3] MA Fuertes JC, C Alonso, JM Pérez. Cisplatin biochemical mechanism of action: from cytotoxicity to induction of cell death through interconnections between apoptotic and necrotic pathways. Curr Med Chem. 2003;10(3):257-66.

Paclitaxel: A Chemotherapeutic with Natural Origins

Although therapeutics used in the treatment of cancer may seem synthetic and artificial, one particular product offered by Taj Accura Pharmaceuticals originated from Mother Nature.

Softaxel(Paclitaxel Injection)30mg,100 mg & 260 mg

 http://www.tajaccura.com/product/paclitaxel-lyophilised-injection/

Facts about Paclitaxel:

• It is an antineoplastic agent used in the treatment of ovarian, breast and lung cancer
• Its natural origins initially extracted from the bark of the Pacific Yew plant, which grows in Northwest America
• Its mechanism of action prevents cell division by binding to the cell’s “skeleton”, which eventually leads to cell death
• Following huge demand, for economical development and in fear of endangering the limited botanical species, this medicine is now created from a semi synthetic pathway, where extracts from other cultivated Yew plants are structurally modified prior to formulation

Paclitaxel is indicated according to the UK guideline body NICE as a second line agent for women with ovarian cancer with platinum resistance/allergy, or as a subsequent therapy to an agent such as carboplatin. Traditionally, paclitaxel was administered as a 24 hour infusion with prior pre-treatment with corticosteroids, antihistamines and H2 receptor antagonists. In a recent Cochrane Review 2011, early studies have shown that a shorter infusion time of 3 hours with the same dose was linked to less adverse effects and severe toxicity.

Conclusion:
Paclitaxel manufactured by Taj Accura Pharmaceuticals is available in 150 mg/25 mL and 300 mg/50 mL injectable dosage forms, as the generic equivalent of Onxol and Taxol. A lyophilised injection formulation is also available, in 100 mg, 250 mg and 500 mg doses.
Ref: Williams C., Byrant A. ‘Short versus long duration infusions of paclitaxel for any advanced adenocarcinoma’ Cochrane Database Syst Review. 2011; Issue 5

Melphalan, a generic oncology product available from Taj Accura Pharmaceuticals

Melphalan is a cytotoxic drug which belongs to a class of medicines known as alkylating agents.
It is an important component of chemotherapy regimens for the treatment of various different types of cancer.
 http://www.tajaccura.com/melphalan-a-generic-oncology-product-now-available-from-taj-accura-pharmaceuticals/

What is Melphalan used for?
Melphalan is used in the treatment of

• Ovarian Cancer
• Breast Cancer
• Multiple Myeloma (cancer of the bone marrow)
• Neuroblastoma (a childhood cancer that often develops in the adrenal gland) and
• Rhabdomyosarcoma (a rare cancer of muscle tissue). [i]

How does Melphalan work?
As mentioned earlier, Melphalan is an alkylating agent, a common class of chemotherapeutic medicines. DNA is made up of four different nucleotides, one of which is known as guanine. Melphalan attaches an alkyl group to guanine thereby causing DNA strands to stick together.
The consequence of this is that the affected cells are no longer capable of synthesising DNA. Without this ability, the cells are unable to divide and so they quickly die off.  
Cancerous cells are characterised by their increased speed of cell division. One consequence of this is that they are more likely to be attacked by Melphalan than healthy cells. As we will see in the next section however, the selectivity is not perfect.

Are there any side effects associated with the use of Melphalan?
Yes, there is the potential for patients using Melphalan to develop side effects, just like other chemotherapeutic drugs. However, it should be noted that these side effects are usually predictable so steps can be taken to minimise or prevent them. The effects are almost always reversible.
Patients are advised to contact their doctor, pharmacist or nurse if they have any questions regarding treatment with Melphalan. Some of the more common side effects include:

• Low blood counts (the decreased production of red and white blood cells in the bone marrow can put patients at risk of picking up a secondary infection. Furthermore, the lower levels of platelets can increase their risk of bleeding)
• Nausea, vomiting or loss of appetite (these are more severe when using higher doses but there are many medicines now available to control these symptoms)
• Hair Loss (this is really only a problem when using high doses of melphalan)
• Mouth ulcers and
• Loss of fertility.

How is Melphalan given?
Melphalan is available as an injection or as tablets. In the case of the injection, the drug can be given as an infusion into a vein or alternatively, as a perfusion into an artery. This will be done by the patient’s doctor or by another trained health professional, never by the patient themselves.
The patient’s doctor will also decide on what dosage to use and whether to administer the injections or the tablets. Different patients receive different treatments because of the variations in weight, height, age, kidney function and several other parameters.
Do patients undergo monitoring during treatment?
Yes, patients will receive regular check-ups at which time they will undergo tests for their blood count, kidney function, liver function and electrolyte levels. Their healthcare professional will also check to see if they have experienced any side effects.

Conclusion
Melphalan Hydrochloride Injections to be used in the treatment different types of cancer are available from Taj Accura Pharmaceuticals at a dose of 50 mg. Taj Accura also provide Melphalan tablets at a dose of 2 mg. Please visit www.tajaccura.com for further details.
Always remember to consult your Doctor or Healthcare Professional if you have any questions about your own health or medications.
Taj Accura Pharmaceuticals are committed to providing affordable pharmaceutical care solutions to health providers and patients globally. Our enthusiastic and highly skilled bi-lingual sales team in English and French are more than welcome to take your queries. We are contactable by emailing info@tajaccura, by phone at + 353 (1) 293 1882 or alternatively by fax at + 353 (1) 293 1883
[i] Facon T, Mary JY, Hulin C et al. (October 2007). “Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial”. Lancet 370 (9594): 1209–18.

COLISTIN 1 MIU

Product Description

---

COLISTIN® is an antibiotic. It belongs to a group of antibiotics called polymyxins.
It contains Colistimethate sodium as an active ingredient
Like all antibiotics, Colistimethate is only active against some bacteria, so it is only suitable for treating some types of infection. Colistimethate is given by injection to treat
• Some serious infections where other antibiotics are not suitable. These infections include some types of pneumonia and some bladder or kidney infections.
• Certain chest infections in patients with cystic fibrosis.

http://www.tajaccura.com/product/colistin/

---

BEFORE YOU ARE GIVEN COLISTIN ®

COLISTIN ® is not suitable for everyone. Some people must not have this injection. Do not have the injection if you:
• are allergic to COLISTIN ® or to another antibiotic called polymyxin B
• have a condition called myasthenia gravis. If you are unsure about anything, ask your doctor before you have the injection.
Your doctor must be especially careful if you:
• have porphyria
• have kidney problems
• are pregnant or breastfeeding.
If you are unsure about anything speak to your doctor.

---

 

Taking other medicines

You must tell your doctor if you are taking any of the following medicines:
• Other antibiotics called aminoglycosides (such as gentamicin, tobramycin, amikacin or netilmicin) or cephalosporins. Having COLISTIN ® at the same time as one of these antibiotics can increase the risk of damage to the kidneys or cause side effects in the ears and parts of the nervous system.
• Muscle relaxant medicines that are often used during general anaesthesia. COLISTIN ® can increase the effects of these drugs.
• Ether, a substance sometimes used as an anaesthetic.
If you need to have a general anaesthetic, make sure that the anaesthetist knows that you are having COLISTIN ®.
Make sure the doctor knows about any other medicines that you are taking, including medicines that you obtained without a prescription.
Pregnancy and breastfeeding• COLISTIN ® is not known to harm the unborn child but, like all medicines, it will only be given to a pregnant woman if it is really needed.
• Small amounts of COLISTIN ® enter the milk. If you cannot stop breastfeeding while you have the injections, you should watch your baby carefully for any signs of illness and tell your doctor if you notice anything wrong.
Driving and operating machinery
Some people have reported side effects such as dizziness, confusion or problems with vision. If you are affected do not drive or operate machinery.

---

HOW COLISTIN ® IS GIVEN

The COLISTIN ® powder is made up into a solution and will be given to you either as an injection or infusion (drip) into a vein. Your doctor will decide how COLISTIN ® should be given and how long your treatment should last. This will usually be at least 5 days. When treating bacterial infections it is important to complete the full course of treatment.
The doctor will calculate the dose depending on the infection you have and how severe it is. It will also depend on your age, weight and how well your kidneys work.
Sometimes, particularly in people with kidney problems, people with cystic fibrosis or in newborn babies, the doctor may measure the level of COLISTIN ® in the blood and adjust the dose accordingly.
The usual dose for patients weighing more than 60kg is between 1 and 2 million units three times a day. The maximum dose is 6 million units in 24 hours.
The usual daily dose for children and adults weighing up to 60 kg is 50,000 to 75,000 units/kg per day, given in 3 doses at approximately 8-hour intervals
People who have moderate or severe kidney problems will probably be given a lower dose.
If you are being treated in hospital or at home by a doctor or nurse and think that you may have missed a dose or been given too much COLISTIN ®, please speak to your doctor or nurse. Too much COLISTIN ® can cause serious side effects.

---

POSSIBLE SIDE EFFECTS

Like all medicines, COLISTIN ® can cause side effects although not everybody gets them.
Some side effects can be serious
Tell the doctor or nurse immediately if you notice any of the following symptoms:
• Wheezing or breathing difficulties which can lead to collapse, a rash, itching or hives on the skin, or sudden swelling of the face, throat or lips. These can be signs of a severe allergic reaction.
The following side effects have also been reported:
• Reactions, such as irritation, at the injection site.
• Kidney problems. These are more likely in patients who already have poor kidneys, or who are given COLISTIN ® at the same time as other medicines that can affect the
kidneys, or who are given a dose that is too high. These problems will normally get better if treatment is stopped, or the dose of COLISTIN ® is reduced.
• Neurological problems such as inability to breathe because of paralysis of the chest muscles, numbness or tingling (especially around the face), dizziness or loss of balance, rapid changes in blood pressure or blood flow (including faintness and flushing), slurred speech, problems with vision, confusion and mental problems (including loss of sense of reality). Side effects that affect the nervous system are more likely to occur when the dose of COLISTIN ® is too high, in people who have poor kidneys or in those who are also receiving muscle relaxants or other medicines with a similar effect on how the nerves work.
If any of these side effects become troublesome or persist, or if you notice any side effects not listed in this leaflet, you should tell your doctor as soon as possible.

---

HOW TO STORE COLISTIN

Keep out of the reach and sight of children. The vials of powder must not be stored above 25°C. The vials must be protected from light by storing in the outer carton. The vials must not be used after the expiry date printed on the carton and vial label. Do not freeze.
The solution of COLISTIN ® should be used immediately, or within 8 hours when stored at temperatures not exceeding 25oC or 24 hours in the refrigerator (2 to 8oC). The vials are for single use. Any unused solution should be discarded. COLISTIN ® should not be used if there is any discoloration or cloudiness of the solution

---

FURTHER INFORMATION

Each vial contains the active ingredient, Colistimethate sodium as an amount of powder equivalent to one million international units. There are no other ingredients.
COLISTIN ® is a creamy white powder for solution for injection in single dose 10ml glass vials. Each carton contains 1 or 10 vials.

Trientine 250mg Capsules

Product Description

Trientine is used for:

Treating Wilson disease in patients for whom other treatments are ineffective or not appropriate.

Trientine is a chelating compound. It works by binding to copper to help remove it from the body.

Do not use Trientine if:

• You are allergic to any ingredient in Trientine
• Contact your doctor or health care provider right away if any of these apply to you.

Before using Trientine:

 Some medical conditions may interact with Trientine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have iron deficiency

Some MEDICINES MAY INTERACT with Trientine. Tell your health care provider if you are taking any other medicines, especially any of the following

Mineral supplements, because the effectiveness of Trientine may be decreased.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Trientine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Trientine:

Use Trientine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Trientine on an empty stomach at least 1 hour before or 2 hours after eating and at least 1 hour before or after taking any other drug, food, or milk.

Swallow Trientine whole. Do not break, crush, or chew before swallowing.

Take Trientine with water.

If you miss a dose of Trientine, take it as soon as possible. If it is almost time for your next  dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2  doses at once.

Ask your health care provider any questions you may have about how to use Trientine.

Important safety information:

Patients receiving Trientine should remain under regular medical supervision throughout the period of drug administration. Patients, especially women, should be closely monitored for evidence of iron deficiency and anemia.

LAB TESTS, including serum iron, serum copper levels, urinary copper levels, and blood counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

Use Trientine with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Trientine, discuss with your doctor the benefits and risks of using Trientine during pregnancy. It is unknown if Trientine is excreted in breast milk. If you are or will be breast-feeding while you are using Trientine, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Trientine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal muscle contractions or spasms; iron deficiency; lupus; muscle weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever; red, swollen, or blistered skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Proper storage of Trientine:

• Store Trientine in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C), in a tightly closed container. Do not freeze. Keep Trientine out of the reach of children and away from pets.

General information:

. If you have any questions about Trientine, please talk with your doctor, pharmacist, or  other health care provider.

• Trientine is to be used only by the patient for whom it is prescribed. Do not share it with  other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Trientine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Trientine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Trientine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Trientine.

For the Consumer

Applies to trientine: oral capsule

As well as its needed effects, trientine (the active ingredient contained in Syprine) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking trientine, check with your doctor or nurse as soon as possible:

More common – Symptoms of anemia

• Unusually pale skin
• unusual tiredness

Rare

• Fever
• general feeling of discomfort, illness, or weakness
• joint pain
• skin rash, blisters, hives, or itching
• swollen glands

Note: Signs of anemia are more likely to occur in children, menstruating women, and pregnant women, who usually need more iron than other patients. If these signs appear during trientine treatment, your doctor will need to do some tests.

For Healthcare Professionals

Applies to trientine: oral capsule

Nervous system

Central nervous system side effects have included dystonia, malaise, myasthenia gravis, and weakness.

Immunologic

Immunologic side effects have included systemic lupus erythematosus.

Hematologic

Hematologic side effects have included iron deficiency and hypochromic microytic anemia. The hypochromic microytic anemia was reported in 4 patients being treated with trientine (the active ingredient contained in Syprine) who had primary biliary cirrhosis.

Musculoskeletal

Musculoskeletal system side effects have included muscle spasm, muscle pain, cramps, and rhabdomyolysis. The rhabdomyolysis was reported in 4 patients being treated with trientine (the active ingredient contained in Syprine) who had primary biliary cirrhosis.

Gastrointestinal

Gastrointestinal side effects have included heartburn, epigastric pain and tenderness, acute gastritis, aphthoid ulcers, abdominal pain, melena, and anorexia. These side effects were reported in 4 patients being treated with trientine (the active ingredient contained in Syprine) who had primary biliary cirrhosis.

Dermatologic

Dermatologic side effects have included thickening, fissuring, and flaking of the skin. These side effects were reported in 4 patients being treated with trientine (the active ingredient contained in Syprine) who had primary biliary cirrhosis.

Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.

Note : This product information is intended only for residents outside of the EU. Taj Accura Pharmaceuticals Limited medicines help to treat and prevent a range of conditions—from the most common to the most challengin

*** Please consult local Prescribing Information for any product before use. This website is an international information resource for healthcare professionals with an interest in disease management.

This website is not intended to replace the advice of a qualified healthcare professional. Above brand is a trademark of the Taj group of companies (Taj Pharmaceuticals Limited).

*The photos shown are samples only. Not all photos of the drug may be displayed. Your medication may look different. If you have questions, ask your pharmacist.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised July 2014. Copyright(c) 2014 Taj Pharma.

Selected from General Medical Drug data included with permission.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.