PACKAGE LEAFLET: INFORMATION FOR THE USER

SLOW-FE Tablets

Ferrous Sulphate (160.0mg)

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 Slow-Fe Tablets are and what they are used for

2.    What you need to know before you use Slow-Fe Tablets

3.    How to use Slow-Fe Tablets

4.    Possible side effects

5.    How to store Slow-Fe Tablets

6.    Contents of the pack and other information

1. WHAT SLOW-FE TABLETS ARE AND WHAT THEY ARE USED FOR

Slow-Fe Tablets contain iron (ferrous sulphate 160mg) in a special ‘slow release’ form designed to prevent or treat anaemia caused by too little iron in the body (iron-deficiency anaemia).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SLOW-FE TABLETS Do not take Slow-Fe Tablets if you:

•    have an allergy (hypersensitivity) to iron or any of the other ingredients of Slow-Fe tablets (see Section 6 ‘What Slow-Fe Tablets contain ’ and end of Section 2),

•    suffer from any iron-storage disorders (eg. haemachromatosis) or blood diseases (eg. haemolytic anaemia or haemosiderosis)

•    suffer from an anaemia not produced by iron deficiency

•    are receiving repeated blood transfusions.

Do not take iron tablets and iron injections at the same time.

Do not give Slow-Fe tablets to children under the age of 6 years.

Warnings and precautions

Consult your doctor if you suffer from:

•    any diseases affecting your stomach or intestines.

Other medicines and Slow Fe

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

Slow Fe tablets taken with the following medicines may have impaired absorption or may reduce the absorption of the other medicine:

•    indigestion medicines (eg. antacids)

•    antibiotics used to treat infections such as tetracyclines or quinolines

•    penicillamine (used to treat arthritis)

•    zinc salts

•    methyldopa (to treat high blood pressure)

•    levodopa and carbidopa (to help control Parkinson’s disease)

•    bisphosphonates (to treat osteoporosis)

•    levothyroxine (to treat an underactive thyroid)

•    any other iron-containing medicines or tonics which your doctor does not know you may be taking

Slow-Fe Tablets with food and drink

Slow-Fe tablets should preferably be taken after food.

Avoid taking the tablets with beverages such as tea or coffee for optimal iron absorption.

Pregnancy and breast-feeding

Slow-Fe tablets can be used throughout pregnancy and breast-feeding to prevent or treat iron deficiency anaemia, with or without additional folic acid.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

There is no evidence that Slow-Fe tablets affect your ability to drive or operate machinery.

Slow-Fe Tablets contain:

• Lactose - if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE SLOW-FE TABLETS

Always take Slow-Fe tablets as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults

Prevention of anaemia: Take one tablet a day.

Treatment of anaemia: Take two tablets a day.

Children over 6 years

For the treatment of anaemia, take one tablet a day.

Swallow the tablet whole with a drink of water and if possible take after food. Do not crush or chew the tablet as this will affect the way the iron is released from the special ‘slow release’ tablet.

Do not take the tablets with tea or coffee which can reduce iron absorption.

This medicine is not recommended for use in children under the age of 6 years.

If you take more Slow-Fe Tablets than you should

Taking too many Slow-Fe tablets may cause abdominal pain, sickness, vomiting, diarrhoea or vomiting of blood.

This product contains iron. Keep out of the reach and sight of children as overdose may be fatal. If you or a child accidentally take too many Slow-Fe tablets, contact your doctor or hospital casualty department immediately. Take the tablets and the carton with you if possible, even if there are no tablets left in it.

If you forget to take Slow-Fe Tablets

If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS

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

STOP taking Slow-Fe tablets and seek medical help immediately if you, or your child, have any of the following rare (may affect up to 1 in 1,000 people) side effects which may be signs of an allergic reaction:

•    difficulty in breathing or swallowing

•    swelling of the face, lips, tongue or throat

•    severe itching of the skin, with a red rash or raised bumps.

Most people who are prescribed these tablets while pregnant benefit from taking them. However, the following side effects may sometimes be experienced:

Common (may affect up to 1 in 10 people)

•    feeling sick (nausea), constipation, diarrhoea, abdominal discomfort/pain.

Uncommon (may affect up to 1 in 100 people)

•    being sick (vomiting), dark stools/ faeces.

Rare (may affect up to 1 in 1,000 people)

•    hypersensitivity reactions (such as rash, redness, itching, raised bumps, and swelling of face).

These effects are often mild and wear off after a few days. If they become severe or last for more than a few days, then tell your doctor.

Dark stools can be caused by unabsorbed iron, an effect that is not harmful. If you are also getting severe stomach pains, tell your doctor immediately.

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

5. HOW TO STORE SLOW-FE TABLETS

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

Store in a dry place. Store in the original pack.

Do not use Slow-Fe tablets after the expiry ‘EXP’ date which is stated on the blister and the carton. The ‘EXP’ date refers to the last day of that month.

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION What Slow-Fe Tablets contain

The active ingredients are: ferrous sulphate (iron sulphate) 160 mg.

The other ingredients are: lactose, hypromellose, cetostearyl alcohol, magnesium stearate, titanium dioxide (E171), talc, polysorbate, yellow iron oxide (E172), indigo carmine (E132).

(see also end of Section 2 for information on lactose).

What Slow-Fe Tablets look like and contents of the pack

Slow-Fe tablets are round, biconvex, greenish white film coated embossed with “CG 503” on one side and plain on the other side. They are available in blister packs of 28 or 150 tablets.

Marketing Authorisation Holder and Manufacturer

Novartis Consumer Health UK Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

For any information about this medicinal product, please contact the Marketing Authorisation Holder.

This medicinal product is authorised in the Member States of the EEA under the following names: This leaflet was last revised in May 2012.

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