PACKAGE LEAFLET: INFORMATION FOR THE USER

SLOW-FE FOLIC Tablets

Ferrous Sulphate (160.0mg) and Folic Acid (0.4mg)

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 Folic Tablets are and what they are used for

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

3.    How to use Slow-Fe Folic Tablets

4.    Possible side effects

5.    How to store Slow-Fe Folic Tablets

6.    Contents of the pack and other information

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

Slow-Fe Folic Tablets contain iron (ferrous sulphate 160mg) and folic acid (0.4mg) in a special ‘slow release’ form designed to minimise the problems of intestinal problems associated with most oral iron products.

Slow-Fe Folic tablets are used to prevent or treat your dietary iron and folic acid deficiency during pregnancy.

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

•    have an allergy (hypersensitivity) to iron or folic acid or any of the other ingredients of Slow Fe-Folic tablets

(see Section 6 and end of Section 2),

•    suffer from any iron-storage disorders (eg. haemachromatosis)

•    suffer from any 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-Folic tablets to children or the elderly.

Warnings and precautions

Consult your doctor if you suffer from :

•    epilepsy and have a lack of folic acid. Taking folic acid supplements can lead to loss of seizure control if your anticonvulsant dosage is not adjusted by your doctor.

•    any disease affecting your stomach or intestines.

•    pernicious anaemia or vitamin B-12 deficiency.

Other medicines and Slow Fe-Folic

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-Folic 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 control Parkinson’s disease)

•    bisphosphonates (to treat osteoporosis)

•    levothyroxine (to treat underactive thyroid)

•    fluorouracil and capecitabine (chemotherapy medications)

•    methotrexate (for arthritis, or used in cancer treatment)

•    sulfasalazine (to treat arthritis or psoriasis)

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

•    any anticonvulsants (ie. medicines to stop fits and epilepsy) such as phenytoin, phenobarbital, primidone, carbamazepine and pheneturide, may lead to decreased seizure control in some patients.

Taking Slow Fe-Folic Tablets with food and drink

Slow Fe-Folic 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-Folic tablets can be used throughout pregnancy and breastfeeding to prevent or treat iron and folic acid deficiency.

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

Driving and using machines

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

Slow Fe-Folic 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 FOLIC TABLETS

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

Adults

Take one tablet daily throughout pregnancy.

In the case of multiple pregnancy the dosage may be increased to two tablets daily.

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 and folic acid are released from the special ‘slow release’ tablet. Do not take the tablets with tea or coffee which can reduce iron absorption.

Children/Elderly

Slow Fe-Folic tablets are not recommended for use in children or the elderly.

If you take more Slow Fe-Folic Tablets than you should

Taking too many Slow Fe-Folic 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-Folic 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-Folic 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-Folic tablets can cause side effects, although not everybody gets them.

STOP taking Slow Fe-Folic tablets and seek medical help immediately if you 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 sometimes occur during Slow-Fe Folic treatment. This is caused by unabsorbed iron and is usually harmless. If you are also getting severe stomach pains, tell your doctor immediately.

If you get any of the 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 FOLIC TABLETS

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

Do not store above 25 °C. Store in the original pack.

Do not use Slow Fe-Folic 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-Folic Tablets contain

The active ingredients are: Ferrous Sulphate 160 mg (iron sulphate) and Folic Acid 0.4 mg.

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

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

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

Slow Fe-Folic tablets are round, biconvex, cream film coated embossed with “CIBA” on one side and TP 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.

4