FECTRIM TABLETS STANDARD, CO-TRIMOXAZOLE 80/400 MG - patient leaflet, side effects, dosage

FECTRIM TABLETS FECTRIM FORTE TABLETS

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• - Keep this leaflet. You may need to read it again.

• - If you have any further questions, ask your doctor or pharmacist.

• - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their signs of illness are the same as yours.

• - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1. What Fectrim is and what it is used for

2. What you need to know before you take Fectrim

3. How to take Fectrim

4. Possible side effects

5. How to store Fectrim

6. Contents of the pack and other information

1. what fectrim is and what it is used for

The name of your medicine is Fectrim Tablets or Fectrim Forte Tablets (called Fectrim in this leaflet) which contains two active substances called trimethoprim and sulphamethoxazole in three strengths:

• Fectrim Tablets (80 mg of Trimethoprim and 400 mg of Sulphamethoxazole)
• Fectrim Forte Tablets (160 mg of Trimethoprim and 800 mg of Sulphamethoxazole)

Both the active substances belong to a group of medicines called antibiotics. Antibiotics are used to treat infections caused by bacteria. Fectrim works against some types of bacteria, therefore it is only suitable for treating some types of infections.

Fectrim can be used to treat:

• or prevent lung infections (pneumonia) caused by the bacteria Pneumocystis jirovecii
• or prevent infections such as toxoplasmosis
• bladder or urinary tract infections
• infections of the chest (chronic bronchitis)
• ear infections (otitis media) in children
• infections such as nocardiosis (bacterial infection affecting the lungs, skin and brain).

Fectrim Tablets and Fectrim Forte Tablets are used in adults and children over 12 years of age.

You must talk to a doctor if you do not feel better or if you feel worse.

2. what you need to know before you take fectrim

Do not take Fectrim tablets if:

• you are allergic to trimethoprim, sulphamethoxazole or any other ingredients of this medicine (listed in section 6)
• you have severe liver or kidney problems
• you have or ever had any blood disorder or anaemia or porphyria (a rare blood problem affecting your skin or nervous system)
• you have reduced amount of the enzyme glucose-6-phosphate dehydrogenase (G6PD)

Fectrim should not be given to infants during the first 6 weeks of life.

Warnings and precautions

Talk to your doctor or pharmacist before taking Fectrim tablets, if:

• potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Fectrim, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk.
• additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
• these potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin.
• the highest risk for occurrence of serious skin reactions is within the first weeks of treatment.
• you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Fectrim, you must not be re-started on Fectrim at any time.
• you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell that you are taking this medicine.
• you have severe allergies or asthma.
• you develop blood related problems.
• you do not have enough folic acid (a vitamin) in your body – which can make your skin pale and make you feel tired, weak and breathless. This is known as anaemia.
• you have any liver diseases (such as jaundice) or kidney problems (lower doses are prescribed).
• you have a problem with your metabolism called phenylketonuria and are on a special diet.
• you have high potassium levels in blood (hyperkalemia) and close monitoring is necessary.
• you are elderly.
• you develop an unexpected worsening of cough and shortness of breath, inform your doctor immediately.

Haemophagocytic lymphohistiocy­tosis

There have been very rare reports about excessive immune reactions due to a dysregulated activation of white blood cells resulting in inflammations (haemophagocytic lymphohistiocy­tosis), which can be life-threatening if not diagnosed and treated early. If you experience multiple symptoms such as fever, swollen glands, feeling weak, lightheaded, shortness of breath, bruising, or skin rash simultaneously or with a slight delay, contact your doctor immediately.

Tests:

Regular blood and urine tests are recommended for patients on long term treatment.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Fectrim.

Other medicines and Fectrim tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription. This is because Fectrim can affect the way some medicines work. Also some other medicines can affect the way Fectrim works.

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines to thin the blood (warfarin)
• pyrimethamine, used to treat and prevent malaria
• medicines to treat diabetes (glibenclamide or tolbutamide, repaglinide, rosiglitazone)
• medicines used after organ transplants or for your immune system (cyclosporin, azathioprine)
• medicines used to treat heart failure or heart rhythm problems (digoxin, amiodarone, procainamide)
• medicines used to treat bacterial infections (such as rifampicin and dapsone)
• methotrexate, used to treat cancer or for your immune system
• phenytoin, used to treat seizures
• medicines that can increase the amount of potassium in your blood, such as diuretics (water tablets such as spironolactone, amiloride) or angiotensin-converting enzyme inhibitors (enalapril, quinapril)
• medicines to treat HIV or AIDS (lamivudine, zidovudine or didanosine)
• amantadine, used to treat Parkinson’s disease
• clozapine, used to treat mental problems
• lidocaine/pri­locaine (in infants)
• loperamide, used to treat diarrhoea

Fectrim tablets with food and drink

You should take Fectrim with some food and drink. This will stop you feeling sick (nausea) or having diarrhea. Drink plenty of water while you are taking Fectrim.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

This medicine should not be used during pregnancy, or when you are breast feeding. Fectrim is excreted in breast milk causing problems in breast-fed infants.

3. how to take fectrim

Always take Fectrim exactly as your doctor has told you. The label on your pack will tell you how much to take and how often to take it. You should check with your doctor or pharmacist if you are not sure.

• The usual dose for acute infections depends on either your age or weight. The recommended dose is:

Your doctor may prescribed you the dose to treat or prevent lung infections (Pneumonia or PCP). The dose and frequency will depend on:

• – the type and severity of infection you have

• – your weight

• – your age

• The doses should be reduced in patients with kidney problems and your doctor shall decide the dose depending on your condition.

If you take more Fectrim tablets than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include vomiting, blurred vision, confusion, skin discolouration or jaundice.

If you forget to take Fectrim tablets

If you forget to take a dose, take it as soon as you remember it and then take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Fectrim tablets

Do not stop taking Fectrim tablets because you feel better. Take the tablets for as long as your doctor has told you or your problem may come back.

4. possible side effects

Like all medicines, Fectrim tablets can cause side-effects, although not everybody gets them.

Stop taking the tablets immediately and seek urgent medical advice if the following occur:

• allergic reactions: skin rashes which may be itchy, skin flushing, swelling of the face, lips, tongue or throat, difficulty breathing, extreme tiredness, joint stiffness, fever, wheezing, abdominal pain, feeling or being sick
• inflamed heart muscle (chest pain, fever, a fast heartbeat, tiredness), systemic lupus erythematosus (SLE-skin rash, hair loss, difficulty breathing and joint pains)
• aseptic meningitis (headache, fever, stiff neck, tiredness, feeling ill and sensitivity of eyes to bright light)
• Very rare, potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2).

Tell your doctor if the following side effects occur:

• effects on blood: changes in the numbers and types of your blood cells. If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin, you should tell your doctor who may want you to have a blood test.
• feeling or being sick, diarrhoea, inflammation of tongue/intestines (difficulty in swallowing, swelling or ulceration of the gullet), inflammation of the pancreas (abdominal pain, being sick, fever unwell); pseudomembranous colitis (causing severe and painful diarrhoea)
• loss of appetite, decreased levels of sodium, low blood glucose, increased levels of potassium (hyperkalaemia)
• Muscle/joint pain or muscle weakness
• liver failure or jaundice (yellowing of the skin or whites of the eyes), changes in levels of liver enzymes
• kidney problems, abdominal pain, difficulty passing urine, blood in urine, crystals in the urine (this can be avoided by drinking plenty of water)
• headache, depression, dizziness, seeing strange or unusual sights (hallucinations), fits, lack of co-ordination (ataxia), drowsiness
• other effects: cough, shortness of breath, swollen skin (angioedema), sensitivity to light, painful red eyes with blurred vision (uveitis), inflammation of blood vessels, colour change of skin (pupura), spinning sensation, ringing in the ears, fungal infections (thrush)

Most commonly, high frequency of side effects are reported in elderly patients.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store fectrim

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date (EXP.) which is stated on the label or carton.

Do not store above 25°C. Store it in a dry place, in well-closed container.

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 protect the environment.

6. contents of the pack and other information

What Fectrim tablets contain

Fectrim tablet contains the active ingredients, trimethoprim and sulphamethoxazole.

Fectrim tablets: 80 mg of trimethoprim and 400 mg of sulphamethoxazole.

Fectrim Forte tablets : 160 mg of trimethoprim and 800 mg of sulphamethoxazole.

Fectrim tablets and Fectrim Forte tablets contain povidone K25, crospovidone and magnesium stearate.

What Fectrim tablets look like and contents of the pack

Fectrim tablets: Flat, white, bevelled tablets, engraved ‘80’ and ‘400’ on the scored side.

Fectrim Forte tablets: White, capsule shaped tablets, engraved ‘160’ and ‘800’ on the scored side.

Fectrim tablets are available in containers of 100, 500 tablets and in blisters of 10, 28, 30 tablets. Fectrim Forte tablets are available in containers of 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Hualan Pharmaceuticals Limited 16/17 College Green, Dublin, D02 V078, Ireland

Manufacturer

DDSA Pharmaceuticals Limited

• 84 Pembroke Road