The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.Source: electronic medicines compendium (emc), DatapharmActive substance: folic acid, ferrous fumarateOfficial document: view the original leaflet on emc →Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

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Pregaday 322mg / 0.35mg film-coated Tablets

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Folic acid, Ferrous fumarate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Folic acid, Ferrous fumarate

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

for Pregaday 322mg/0.35mg film-coated Tablets (referred to as Pregaday in this leaflet) contains two active substances Ferrous Fumarate 322.00mg (an iron supplement)

and Folic Acid 0.35mg (a vitamin supplement). These work together in the medicine. Pregaday belongs to a group of medicines called haematinics (Iron in combination with Folic Acid). Pregaday works as a supplement. It provides the body with more iron and folic acid. These are important substances that your body needs to form red blood cells. If you do not have the right amount of these substances it is possible that you may develop anaemia. Pregaday is used to prevent and treat low levels of iron and folic acid in the blood during pregnancy after the first thirteen weeks. During pregnancy the body's demands for iron and folic acid increase. Iron is important for the health of the mother and developing baby. Not enough iron may lead to anaemia in either the mother or baby. It is therefore important that the body gets enough iron for both the mother and the developing baby. Folic acid is very important for the development of a baby during pregnancy. It is therefore important that the body gets enough folic acid for both the mother and the developing baby. You must talk to a doctor if you do not feel better or if you feel worse.

2. What you need to know before Children There is no relevant use of Pregaday you take Pregaday Do not take Pregaday:

if you are allergic to Ferrous Fumarate and Folic Acid or any of the other ingredients of this medicine (listed in section 6)
if you are less than 13 weeks pregnant
if you are breast-feeding or trying to become pregnant
if you have been told you suffer from Vitamin B12 deficiency
if you suffer from a blood disorder
if you have had or are having repeated blood transfusions
if you have a stomach ulcer or other digestive conditions such as regional enteritis or ulcerative colitis
if you are suffering from anaemia that is not due to a lack of iron If any of the above applies to you talk to your doctor or pharmacist. Warnings and precautions Talk to your doctor before taking Pregaday
if you have been or you are being treated for a stomach ulcer
if you have had or you have a folate dependent tumour
if you have had all or part of your stomach removed Pregaday contains iron. Keep out of reach and sight of children, as overdose may be fatal.

Zinc
Any other medicine, including in children. medicines obtained without a prescription This medicine contains less than 1 mmol sodium (23mg) per tablet, that Pregaday with food and drink is to say essentially 'sodium free'. If you drink tea, coffee or milk or eat eggs at the same time as taking Other medicines and Pregaday Pregaday your body may absorb less Tell your doctor if you are taking of the iron supplement, which may any other medicines. reduce the effect of this medicine.
Antibiotics e.g. fluoroquinolones, Pregnancy and breast-feeding cotrimoxazole, chloramphenicol, If you are pregnant or think you may sulphonamides, tetracyclines, be pregnant, ask your doctor for neomycin (used for infections)
Anticonvulsant medicines (used for advice before taking this medicine. Only use if you are more than 13 epilepsy) weeks pregnant. Do not use if you
Antacids are breast-feeding or trying to
Penicillamine (used for rheumatoid become pregnant. arthritis) Driving and using machines.
Sulfasalazine (used for rheumatoid There are no known effects on arthritis and bowel disease, e.g. driving or using machines. Crohn's disease)
Cholestyramine (used for reducing 3. How to take Pregaday blood cholesterol or control diarrhoea) Always take this medicine exactly as described in this leaflet or as your
Levodopa or Carbidopa (used for doctor, or pharmacist has told you. Parkinson's disease) Check with your doctor or
Thyroxine (used for thyroid pharmacist if you are not sure. disease)
Bisphosphonates (used for bone IMPORTANT: Your doctor or disease) pharmacist will choose the dose that is right for you. Your dose will be
Aminopterin and Methotrexate shown clearly on the label that your (used for certain cancers) pharmacist puts on your medicine.
Pyrimethamine (used for malaria) If it does not, or you are not sure,
Trientine (used for Wilson's ask your doctor or pharmacist. disease) DO NOT EXCEED THE STATED
Methyldopa (used for high blood DOSE. pressure)

PB Pregaday 225 3503 0 UK.indd 2

Too much iron can be harmful. Swallow the tablet whole with a glass of water. The recommended dose for adults

The usual dose is one tablet each day
The tablets come in a pack with the days of the week marked on the back. This will help you to remember to take your medicine. Make sure you press out the tablet for the correct day of the week. If you take more Pregaday than you should If you accidentally take too much, contact the nearest hospital casualty department or your doctor immediately. Symptoms of an overdose include stomach pain, diarrhoea or being sick, within an hour of taking too much. Heart problems or collapse may follow. If you forget to take Pregaday If you miss a tablet take one when you remember. Never take two tablets on the same day. If you miss several tablets take a single tablet and talk to your doctor. If you stop taking Pregaday Keep taking this medicine for as long as your doctor or pharmacist tells you to. Do not stop taking this medicine just because you feel better. 225 3503 0

27.04.20 07:59

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

How to take it

Pregaday 4. Possible side effects 5. How to store Pregaday 6. Contents of the pack and other information

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Seek immediate medical help if you have an allergic reaction. This includes any of the following symptoms:

Difficulties in breathing
Swelling of your eyelids, face or lips
Rash or itching Not known: frequency cannot be estimated from the available data
Upset stomach
Anorexia (e.g. loss of appetite)
Sickness
Constipation
Diarrhoea
Darkening of stools 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 website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

Pregaday Keep this medicine out of the sight and reach of children. An overdose can be fatal. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Store below 25°C. Keep the blister in the outer carton in order to protect from light. 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.

Contents of the pack and other information

What Pregaday contains

The active substances are Ferrous Fumarate and Folic Acid. Each tablet contains 322mg ferrous fumarate (equivalent to 100mg iron) and 0.35 mg folic acid.
The other ingredients are maize starch, sodium lauryl sulphate, gelatin and liquid paraffin. The ingredients in the tablet coat are hydroxypropylmethyl cellulose (E464), hydroxypropyl cellulose (E463), red iron oxide (E172), titanium dioxide (E171), and either propylene glycol, or acetylated monoglycerides.

What Pregaday looks like and contents of the pack Pregaday film-coated tablets are round and brownish pink with 'PREGADAY' written on one side. Pregaday comes in cartons containing 28 tablets (2 calendar blister packs of 14). Marketing Authorisation Holder RPH Pharmaceuticals AB, Box 603, 101 32 Stockholm, Sweden. Manufacturer Haupt Pharma Wuelfing GmbH, Bethelner Landstrasse 18, Gronau/Leine, 31028, Germany. This leaflet was last revised in 05/2020. Other sources of information

If this leaflet is difficult to see or read or you would like it in a different format, please contact RPH Pharmaceuticals AB, Box 603, 101 32 Stockholm, Sweden.

Frequently asked questions about Pregaday 322mg / 0.35mg film-coated Tablets

How do I take Pregaday 322mg / 0.35mg film-coated Tablets?

Pregaday 322mg / 0.35mg film-coated Tablets comes as tablet containing 322mg / 0.35mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Pregaday 322mg / 0.35mg film-coated Tablets?

The active substance in Pregaday 322mg / 0.35mg film-coated Tablets is folic acid, ferrous fumarate.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Pregaday 322mg / 0.35mg film-coated Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Pregaday 322mg / 0.35mg film-coated Tablets without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Source: electronic medicines compendium (emc), Datapharm
Active substance: folic acid, ferrous fumarate
Official document: view the original leaflet on emc →

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Ferrous fumarate (6 medicines), Folic acid (9 medicines), Folic acid, ferrous fumarate (1 medicine)

See every medicine containing this substance, or browse the full A–Z of active substances.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+

Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Pregaday Tablets are indicated during the second and third trimester of pregnancy for prophylaxis against iron deficiency and megaloblastic anaemia of pregnancy. Pregaday Tablets are not intended as a treatment for established megaloblastic anaemia.

There is evidence that a daily intake of 100mg of elemental iron in the ferrous form is adequate to prevent development of iron deficiency in expectant mothers. If a mild iron deficiency is present when Pregaday Tablets administration is started, this will be corrected by increased absorption of iron.

The daily folate requirement rises steeply during the final trimester of pregnancy, and evidence of maternal depletion may be found. To ensure normal tissue folate levels in the mother after delivery a daily supplement of about 300 micrograms is required during the second and third trimester of pregnancy. This does not obscure the blood picture of addisonian pernicious anaemia.

4.2. Posology and method of administration

Adults

It is usual to begin therapy with Pregaday Tablets about the thirteenth week of pregnancy (see precautions) either as routine prophylaxis or selectively if the haemoglobin concentration is less than 11g/100ml (less than 75% normal).

One tablet should be taken daily by mouth.

Paediatric Population

There is no relevant use of Pregaday Tablets in the paediatric population.

4.3. Contraindications

Hypersensitivity to the active substances or any of the excipients listed is section 6.1.

Known hypersensitivity to the product, Vitamin B12 deficiency, paroxysmal nocturnal haemoglobinuria, haemosiderosis, haemochromatosis, active peptic ulcer, repeated blood transfusion, regional enteritis and ulcerative colitis.

Pregaday Tablets must not be used in the treatment of anaemias other than those due to iron deficiency.

4.4. Special warnings and precautions for use

The label will state

“Important warning: Contains Iron. Keep out of reach and sight of children, as overdose may be fatal”.

This will appear on the front of the pack within a rectangle in which there is no other information.

Some post-gastrectomy patients show poor absorption of iron. Care is needed when treating iron deficiency anaemia in patients with treated or controlled peptic ulceration. Caution should be exercised when administering folic acid to patients who may have folate dependent tumours.

Since anaemia due to combined iron and vitamin B12 or folate deficiencies may be microcytic in type, patients with microcytic anaemia resistant to therapy with iron alone should be screened for vitamin B12 or folate deficiency.

Paediatric population

Pregaday Tablets should be kept out of the reach of children.

4.5. Interaction with other medicinal products and other forms of interaction

Iron reduces the absorption of penicillamine. Iron compounds impair the bioavailability of fluoroquinolones, levodopa, carbidopa, thyroxine and bisphosphonates.

Absorption of both iron and antibiotic may be reduced if Pregaday is given with tetracycline.

Absorption of both iron and zinc are reduced if taken concomitantly. Concurrent administration of antacids may reduce absorption of iron. Co- trimoxazole, chloramphenicol, sulphasalazine, aminopterin, methotrexate, pyrimethamine or sulphonamides may interfere with folate metabolism. Serum levels of anticonvulsant drugs may be reduced by administration of folate.

Oral chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.

Some inhibition of iron absorption may occur if it is taken with cholestyramine, trientine, tea, eggs or milk.

Administration of oral iron may increase blood pressure in patients receiving methyldopa.

Coffee may be a factor in reducing iron bioavailability. Neomycin may alter the absorption of iron.

4.6. Fertility, pregnancy and lactation

Pregnancy

The use of Pregaday Tablets may be considered during first trimester of pregnancy, if necessary.

There are no or limited amount of data from the use of Folic Acid in pregnant women therefore a minority of them are not protected by physiological doses. The development of anaemia despite prophylaxis with Pregaday Tablets calls for investigation.

Breast-feeding

It is unknown whether Ferrous Fumarate and Folic Acid / metabolites are excreted in human milk.

A risk to the newborns/infants cannot be excluded.

Fertility

No fertility data is available

4.7. Effects on ability to drive and use machines

Pregaday Tablets has no influence on the ability to drive and use machines.

4.8. Undesirable effects

Very rare (<1/10,000)

Very rare (<1/10,000):

Rarely allergic reactions may occur.

Not known (cannot be estimated from the available data)

Not known: Gastrointestinal disorders

Gastro-intestinal discomfort, anorexia, nausea, vomiting, constipation, diarrhoea.

Not known: Renal and urinary disorders

Darkening of the stools may occur.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme on the MHRA website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Symptoms

Symptoms and signs of abdominal pain, vomiting and diarrhoea appear within 60 minutes. Cardiovascular collapse with coma may follow. Some improvement may occur after this phase which, in some patients, is followed by recovery. In others, after about 16 hours, deterioration may occur involving diffuse vascular congestion, pulmonary oedema, convulsions, anuria, hypothermia, severe shock, metabolic acidosis, coagulation abnormalities and hypoglycaemia.

Management

Vomiting should be induced immediately, followed as soon as possible by parenteral injection of desferrioxamine mesylate, and then gastric lavage. In the meantime, it is helpful to give milk and/or 5% sodium bicarbonate solution by mouth.

Dissolve 2g desferrioxamine mesylate in 2 to 3ml of water for injections and give intramuscularly. A solution of 5g desferrioxamine in 50 to 100ml of fluid may be left in the stomach. If desferrioxamine is not available, leave 300ml of 1 % to 5 % sodium bicarbonate in the stomach. Fluid replacement is essential.

Recovery may be complicated by long-term sequelae such as hepatic necrosis, pyloric stenosis or acute toxic encephalitis which may lead to CNS damage.

Paediatric population

Acute overdose of oral iron requires emergency treatment. In young children 200-250mg/kg Ferrous Fumarate is considered to be extremely dangerous.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

⚠ Not the same combination. This medicine contains Folic acid, Ferrous fumarate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.

ACIFOL 5 mg prescription partial — not the same combinationACIDUM FOLICUM · taken by mouth

Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako