Patient Information Leaflet

Septrin® 160 mg/800 mg Forte Tablets

The name of your medicine is Septrin® 160 mg/800 mg Forte Tablets, but will be referred to as Septrin® throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Septrin® is and what it is used for

2.    Before you take Septrin^®

3.    How to take Septrin® 160 mg/800 mg Forte Tablets

4.    Possible side effects

5.    How to store Septrin®

6.    Further information

1.    WHAT SEPTRIN® IS AND WHAT IT IS USED FOR

Septrin® 160 mg/800 mg Forte Tablets (called ‘Septrin®' in this leaflet) are made up of two different medicines called sulfamethoxazole and trimethoprim. These medicines are sometimes given the combined name co-trimoxazole. Both belong to a group of medicines called antibiotics. They are used to treat infections caused by bacteria. Like all antibiotics, Septrin^® only works against some types of bacteria. This means that it is only suitable for treating some types of infections. Septrin^® can be used to treat or prevent:

•    lung infections (pneumonia or PCP) caused by a bacteria called Pneumocystis jiroveci (previously known as

Pneumocystis carinii)

•    infections caused by a bacteria called Toxoplasma (toxoplasmosis). Septrin^® can be used to treat:

•    bladder or urinary tract infections (water infections)

•    lung infections such as bronchitis

•    ear infections such as otitis media

•    an infection called nocardiosis, it can affect the lungs, skin and brain.

2.    BEFORE YOU TAKE SEPTRIN®

Do not take Septrin® if:

•    you are allergic (hypersensitive) to sulfamethoxazole, trimethoprim or co-trimoxazole or any of the other ingredients of Septrin^® (see section 6: Further information)

•    you are allergic to sulphonamide medicines. Examples include sulphonylureas (such as gliclazide and glibenclamide) or thiazide diuretics (such as bendroflumethiazide - a water tablet)

•    you have liver or kidney problems

•    you have ever had a problem with your blood

•    it is for your child and they are less than 6 weeks old or were premature. Unless it is for the treatment or prevention of PCP. In this case, babies should be at least 4 weeks old.

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

Take special care with Septrin®

Before you take Septrin®, tell your doctor or pharmacist if:

•    you have severe allergies or asthma

•    potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Septrin® 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.

•    if you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Septrin^® you must not be restarted on Septrin^® at any time.

•    if you develop a rash or these skin symptoms, stop taking Septrin®, seek urgent advice from a doctor and tell him that you are taking this medicine.

•    you have been told that you have a rare blood problem called porphyria, which can affect your skin or nervous system

•    you don't 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 ever had jaundice which can cause yellowing of your skin or the whites of your eyes

•    you have a problem with your metabolism called phenylketonuria and are not on a special diet to help your condition

•    you are elderly

•    you are underweight or malnourished

•    you have been told by your doctor that you have a lot of potassium in your blood.

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

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Septrin^® can affect the way some medicines work. Also some other medicines can affect the way Septrin^® works.

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

•    Diuretics (water tablets), which help increase the amount of urine you produce

•    Pyrimethamine, used to treat and prevent malaria, and to treat diarrhoea

•    Ciclosporin, used after transplant operations or for your immune system

•    Medicines used to thin the blood such as warfarin

•    Phenytoin, used to treat epilepsy (fits)

•    Medicines for diabetes, such as glibenclamide, glipizide or tolbutamide (sulphonylureas)

•    Medicines to treat problems with the way your heart beats such as digoxin or procainamide

•    Amantadine, used to treat Parkinson's disease, multiple sclerosis,

‘flu or shingles

•    Medicines to treat HIV (Human Immunodeficiency Virus), called zidovudine or lamivudine

•    Medicines that can increase the amount of potassium in your blood, such as diuretics (water tablets, which help increase the amount of urine you produce), steroids (like prednisolone) and digoxin

•    Methotrexate, a medicine used to treat cancer or for your immune system.

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

Taking Septrin® with food and drink

You should take Septrin® with some food or drink. This will stop you feeling sick (nausea) or having diarrhoea. Although it is better to take it with food, you can still take it on an empty stomach.

Drink plenty of fluid such as water while you are taking Septrin®.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, planning to get pregnant, or breast-feeding.

3. HOW TO TAKE SEPTRIN® 160 MG/800 MG FORTE TABLETS

Always take Septrin^® 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.

Usual Dose

Adults and children over 12 years

•    The usual dose is one tablet in a morning and one tablet in an evening.

•    Septrin® should be taken for at least five days.

•    Make sure that you finish the course of Septrin® which your doctor has prescribed.

Septrin® 160 mg/800 mg Forte Tablets are not usually given to children under 12 years old. If they have been given to your child, please speak to your doctor or pharmacist for more information.

Special Dose

The dose of Septrin^® and how long you need to take it depends on the infection you have and how bad it is. Your doctor may prescribe you a different dose or length of course of Septrin^® to

•    treat urinary tract (water) infections

•    treat and prevent lung infections caused by the bacteria Pneumocystis jiroveci

•    treat infections caused by the bacteria Toxoplasma (toxoplasmosis) or Nocardia (nocardiosis).

If you have kidney problems your doctor may

•    prescribe a lower dose of Septrin®

•    take blood to test whether the medicine is working properly.

If you take Septrin^® for a long time your doctor may

•    take blood to test whether the medicine is working properly

•    prescribe folic acid (a vitamin) for you to take at the same time as Septrin^®.

If you take more Septrin^® than you should

If you take more Septrin® than you should, talk to your doctor or go to a hospital straight away. Take the medicine pack with you.

If you have taken too much Septrin® you may

•    feel or be sick

•    feel dizzy or confused.

If you forget to take Septrin^®

•    If you forget to take a dose, take it as soon as you remember it.

•    Do not take a double dose to make up for the forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines Septrin® can cause side effects, although not everybody gets them. You may experience the following side effects with this medicine.

Stop taking Septrin^® and tell your doctor immediately if you have an allergic reaction. Chances of an allergic reaction is very rare (fewer than 1 in 10,000 people are affected), signs of an allergic reaction include

Allergic reactions

•    Difficulty in breathing

•    Fainting

•    Swelling of face

•    Swelling of mouth, tongue or throat which may be red and painful and/or cause difficulty in swallowing

•    Chest pain

•    Red patches on the skin

Very Common (more than 1 in 10 people)

•    High levels of potassium in your blood, which can cause abnormal heart beats (palpitations).

Common (less than 1 in 10 people)

•    An infection called thrush or candidiasis which can affect your mouth or vagina. It is caused by a fungus

•    Headache

•    Feeling sick (nausea)

•    Diarrhoea

•    Skin rashes.

Uncommon (less than 1 in 100)

•    Being sick (vomiting).

Very Rare (less than 1 in 10,000 people)

•    Fever (high temperature) or frequent infections

•    Sudden wheeziness or difficulty breathing

•    Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see Take special care with Septrin®).

•    Mouth ulcers, cold sores and ulcers or soreness of your tongue

•    Skin lumps or hives (raised, red or white, itchy patches of skin)

•    Blisters on your skin or inside your mouth, nose, vagina or bottom

•    Inflammation of the eye which causes pain and redness

•    The appearance of a rash or sunburn when you have been outside (even on a cloudy day)

•    Low levels of sodium in your blood

•    Changes in blood tests

•    Feeling weak, tired or listless, pale skin (anaemia)

•    Heart problems

•    Jaundice (the skin and the whites of your eyes turn yellow).

•    This can occur at the same time as unexpected bleeding or bruising

•    Pains in your stomach, which can occur with blood in your faeces (poo)

•    Pains in your chest, muscles or joints and muscle weakness

•    Arthritis

•    Problems with your urine. Difficulty passing urine. Passing more or less urine than usual. Blood or cloudiness in your urine.

•    Kidney problems

•    Sudden headache or stiffness of your neck, accompanied by fever (high temperature)

•    Problems controlling your movements

•    Fits (convulsions or seizures)

•    Feeling unsteady or giddy

•    Ringing or other unusual sounds in your ears

•    Tingling or numbness in your hands and feet

•    Seeing strange or unusual sights (hallucinations)

•    Depression

•    Muscle pain and/or muscle weakness in HIV patients. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.

This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

5.    HOW TO STORE SEPTRIN®

Keep out of the sight and reach of children.

Do not take the tablets after the expiry date shown on the bottle label and carton.

Do not store above 25°C.

Store in the original package with the leaflet.

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 protect the environment.

6.    FURTHER INFORMATION

Each tablet contains 800 mg sulfamethoxazole and 160 mg trimethoprim.

Septrin® is made up of two different medicines called sulfamethoxazole and trimethoprim. These medicines are

sometimes given the combined name co-trimoxazole.

Also contains: povidone, sodium starch glycollate, magnesium stearate and docusate sodium.

Septrin® 160 mg/800 mg Forte Tablets are white, elongated tablets, plain on one side. They are biconvex and are scored along the shorter axis.

Septrin® 160 mg/800 mg Forte Tablets are available in blister packs of 50 and 100 tablets.

Who manufactured your medicine

Septrin® 160 mg/800 mg Forte Tablets are manufactured by Alcala Farma, S.L, Avenida de Madrid, 82, Alcala de Henares 28802, Madrid, Spain and is procured from within the EU and repackaged by Product Licence Holder: Beachcourse Limited, 20 Alliance Court, Alliance Road, London W3 0RB.

PL 16378/0570    |POM|

Revision Date: 01.02.2016 Ref. SEPTFOR

Septrin® is a registered trademark of Aspen Global Incorporated.

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