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Selexid 200mg Tablets

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Patient Information Leaflet

Selexid® 200mgTablets

(pivmecillinam hydrochloride)

Please 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 become serious, or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.

The name of your medicine is Selexid 200mg Tablets but will be referred to as Selexid throughout the remainder of the leaflet.

In this leaflet:

1.    What Selexid is and what it is used for

2.    Before you take Selexid

3.    How to take Selexid

4.    Possible side effects

5.    How to store Selexid

6.    Further information

1.    What Selexid is and what it is used for

Selexid belongs to a group of medicines called penicillin's. It is a type of antibiotic.

Selexid works by killing germs (bacteria) that cause infections. If the infection is not treated germs can continue to grow in your body. The infection will make you feel very unwell, and could even be life-threatening.

Selexid is used to treat:

•    Infections of the bladder or tubes leading from the kidneys (urinary tract infections).

•    Infections caused by a bacteria called Salmonella (salmonellosis).

2.    Before you take Selexid Do not take Selexid

•    If you are allergic (hypersensitive) to pivmecillinam or any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.

•    If you are allergic (hypersensitive) to other antibiotics. Such antibiotics include penicillin or cephalosporins.

•    If you know that your food pipe has become narrow.

•    If you know that you have any blockages in your digestive system.

•    If you know you have any condition that may reduce the amount of a substance called carnitine in your body. Such conditions include primary carnitine deficiency or kidney dialysis. Do not give this medicine to a baby under three months old.

Take special care with Selexid

Before you take Selexid tell your doctor:

•    If you have problems with your kidneys.

•    If you know that you have a condition called porphyria.

•    If you are taking other medicines used to treat epilepsy, called valproic acid or valproate.

•    If you are taking another antibiotic called pivampicillin.

•    If you have recently taken a course of Selexid.

•    If you have been taking Selexid for a long time already.

If you take Selexid for a long time your doctor may take regular blood tests. This is to check if your kidneys and liver are working properly.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription. You must tell your doctor or pharmacist if you are taking any of the following medicines:

•    Methotrexate: for arthritis or psoriasis. You may need to take a different dose of methotrexate.

•    Probenecid: for gout. This may increase the effect of Selexid.

•    Valproic acid or valproate: for epilepsy.

•    Any other antibiotic: for treating an infection.

This may increase the effect of Selexid.

Taking Selexid with food and drink

Tablets must be swallowed whole during or immediately after a meal with at least half a glass of water, while sitting or standing.

It is important to take your medicine with plenty of liquid. This will stop you getting mouth ulcers or ulcers in your food pipe. Please read section 4 of this leaflet so you can spot any signs this may be happening to you.

Pregnancy and breast-feeding

Please ask your doctor or pharmacist for advice before taking Selexid:

•    If you are pregnant, or think you are pregnant.

•    If you are breast-feeding.

Tell your doctor if you become pregnant while taking this medicine.

Driving and using machines

Usually your medicine may have very little effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines.

3. How to take Selexid

Always use Selexid exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much Selexid to take

Your doctor will tell you how many tablets to take, or give to your child. Your doctor will tell you how many times each day to take your medicine. You should take the medicine at equally spaced times in the day. Remember to always swallow the tablets whole during or immediately after a meal and with at least half a glass of water, while sitting or standing. It is very important to take all the medicine your doctor has told you to take.

Urinary Tract Infections:

Adults and children weighing more than 40 kg:

•    Acute infection:

The usual starting dose is 2 tablets taken immediately. Then take one tablet every 8 hours. Continue until you have taken all 10 tablets in the pack.

•    Repeated infection:

The usual dose is 6-8 tablets each day. Take two tablets 3 or 4 times each day.

For other type of infections or for children weighing less than 40 kg:

Your doctor will prescribe the right dose for you.

If you take more Selexid than you should

Tell your doctor straight away. You may need to stop taking this medicine. You may be sick, or feel sick, or get an upset stomach.

If you forget to take Selexid

If you forget to take your medicine, take it as soon as you remember. If you can, take it during or immediately after a meal, but always take it with half a glass of water, while sitting or standing. Then take the next dose at the usual time.

If you stop taking Selexid

It is very important to take all the medicine that your doctor has told you to take. You must finish this medicine even if you feel better. You must do this because otherwise you may feel ill again. If you have any further questions about taking this medicine, please ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Selexid can cause side effects, although not everybody gets them.

Important side effects to look out for:

You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction:

   You have difficulty breathing.

   Your face or throat swell.

   Your skin develops a severe rash or areas of sudden swelling.

Other possible side effects:

Digestive problems:

Common side effects (probably affect less than 1 in 10 people)

•    Being sick (vomiting).

•    Feeling sick (nausea).

•    Indigestion.

•    Stomach pain.

•    Diarrhoea. This may be because your bowel is inflamed (colitis).

•    Trouble chewing or swallowing your food. This may be due to mouth ulcers, ulcers in your food pipe or inflammation of your food pipe, from taking the tablets with insufficient fluids.

Side effects where the number of people affected is not known:

•    Inflamed bowel. This may be due to taking this medicine. Skin problems:

Uncommon side effects (probably affect less than 1 in 100 people)

•    Rash.

Side effects where the number of people affected is not known:

•    Hives (urticaria).

•    Itching skin (pruritus).

Liver problems:

Side effects where the number of people affected is not known:

•    Yellowing of the skin or eyes.

•    Unusually dark urine.

•    Small changes in blood test results. Your doctor can explain this more.

Blood problems:

Side effects where the number of people affected is not known:

•    Bruising or bleeding more easily.

•    Getting a fever or infections more often.

Changes to certain cells found in your blood may cause these symptoms.

Nervous system problems:

Uncommon side effects (probably affect less than 1 in 100 people)

•    Headache

•    Dizziness

•    Light-headedness

General problems:

Uncommon side effects (probably affect less than 1 in 100 people)

•    Tiredness or lack of energy Other problems:

Side effects where the number of people affected is not known:

•    Muscle weakness or muscle loss. Not enough of a substance called carnitine in your body may cause these symptoms. If any of the side effects become serious, or you notice any side effects not listed in this leaflet, 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 Selexid

Keep out of the sight and reach of children.

Do not use the tablets after the expiry date on the carton. The expiry date is the last day of that month. Do not store above 25°C. Store in a dry place.

Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.

6.    Further information

Selexid are round, white tablets, with an imprint of a lion on one side and “137” on the other.

Each tablet contains 200 milligrams of the active ingredient pivmecillinam hydrochloride.

Also contains: cellulose microcrystalline, hydroxypropylcellulose, magnesium stearate, hypromellose, simethicone and synthetic paraffin.

Selexid is available in blister packs of 10, 20, 30 and 100 tablets.

Manufactured by: Recipharm Strangnas AB, Mariefredsvagen 35 S-645 41 Strangnes, Sweden. Procured from within the EU. Product Licence Holder: Quadrant Pharmaceuticals Ltd,

Lynstock House, Lynstock Way, Lostock, Bolton BL6 4SA. Repackaged by Maxearn Ltd, Bolton BL6 4SA.

Selexid 200mg Tablets PL 20774/1420

Selexid is a registered trademark of LEO Pharma A/S Date of preparation 10th April 2015

PP1/1420/V2