FERROUS SULFATE TABLETS 200MG – patient leaflet, side effects, dosage

1. What Ferrous Sulfate Tablets are and what they are used for

Ferrous Sulfate tablets belong to a group of medicines called iron supplements. These medicines work by replacing body iron. Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, it cannot produce the number of normal red blood cells needed to keep you in good health. This condition is called irondeficiency anaemia. Ferrous Sulfate tablets are used for the prevention and treatment of iron-deficiency anaemia.

2. What you need to know before you take Ferrous Sulfate Tablets

Do not take Ferrous Sulfate Tablets and tell your doctor if you:

• are allergic to the active substance, iron salts, or any of the other ingredients of this medicine (listed in section 6).
• are receiving repeated blood transfusions.
• are receiving iron intravenously.
• have a disorder in which there is excessive absorption and storage of iron such as haemochromatosis.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ferrous Sulfate tablets if you have:

• haemolytic anaemia
• a blood disease (haemoglobinopathy)
• an iron storage or absorption disease
• gastrointestinal disease
• difficulties swallowing.

Due to the risk of mouth ulceration and tooth discolouration, tablets should not be sucked, chewed or kept in the mouth but swallowed whole with water. If you cannot follow this instruction or have difficulty swallowing, please contact your doctor.

If you accidentally choke on a tablet, please contact your doctor as soon as possible. This is because there is a risk of ulcers and narrowing of the bronchus occurring if the tablet enters the airways. This may result in persistent coughing, coughing up blood and/or feeling out of breath, even if the choking happened days to months before these symptoms occurred. Therefore you need to be urgently assessed to make sure that the tablet doesn’t damage your airways.

Other medicines and Ferrous Sulfate Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially:

• tetracyclines (to treat infections)
• ciprofloxacin, norfloxacin, ofloxacin (to treat infections)
• colestyramine

• antacids (containing magnesium or aluminium)

  • medicines containing zinc, calcium, phosphorus or trientine
  • methyldopa (to treat high blood pressure)
  • penicillamine (for rheumatoid arthritis)
  • levodopa (for Parkinson’s disease)
  • ascorbic acid (vitamin C)
  • iron-binding agents such as phosphates, oxalates and components of tea, coffee and milk which can impair the absorption of iron
  • bisphosphonates (such as alendronic acid or disodium etidronate) used generally for osteoporosis
  • dimercaprol used for the treatment of acute poisoning by certain heavy metals
  • thyroid hormones such as levothyroxine used for the treatment of an under active thyroid. Oral iron reduces the absorption of levothyroxine (thyroxine) thus should be taken at least 2 hours apart.

Pregnancy and breast-feeding

This medicine is recommended for use during pregnancy and whilst breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Ferrous Sulfate Tablets contain sucrose

Each tablet contains 70.47 mg of sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Ferrous Sulfate Tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the tablet whole with water. Do not suck, chew or keep the tablet in your mouth. Food and drink

Ferrous Sulfate tablets should not be taken within one hour before or two hours after eating or drinking the following products: tea, coffee, milk, eggs and whole grains. These products can reduce the absorption of iron. Meat and products containing vitamin C can increase the absorption of iron. Follow the advice of your dietician or doctor when taking Ferrous Sulfate tablets with any of the food or drink listed.

Swallow the tablets whole with water. Although iron preparations are best absorbed on an empty stomach, they may be taken after food to reduce gastrointestinal side effects. The recommended dose is:

Adults and the elderly

To prevent anaemia - one tablet daily.

To treat anaemia - one tablet 2 - 3 times daily.

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Oral Use Ferrous Sulfate

200mg

All patients but especially elderly patients and patients with difficulty swallowing may also be at risk of ulceration of the throat, oesophagus (the tube that connects your mouth with your stomach). If the tablet enters the airways, there may be a risk of ulceration of the bronchus (the major air passages of the lungs), resulting in bronchial narrowing.

If you forget to take Ferrous Sulfate Tablets

Children 6-12 years

1000 Tablets

1. 6.

   Contents of the pack and other information

   ferrous sulfate #200 mg tablets

If you forget to take a dose, take the missed dose as soon as you remember. If your next dose is due within the next two hours, take a single dose straight away and skip the next. Do not take a double dose to make up for a forgotten dose.

Treatment:

Children weighing over 22 kg: one tablet a day.

What Ferrous Sulfate Tablets contains:

200 mg Tablets

Children weighing over 44 kg: one tablet twice a day.

The active substance is ferrous sulfate BP. Each tablet contains 200mg of the active substance ferrous sulfate BP equivalent to 65mg ferrous iron.

Children weighing over 66 kg: one tablet three times a day.

Reporting of side effects

4. Possible side effects

A liquid preparation maybe more appropriate for children.

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 (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

The other ingredients are:

Oral use. Read the package leaflet before use. Store in a cool dry place. Follow the recommended doses below or use as directed by your doctor.

Children under 6 years or weighing less than 22 kg

Core: stearic acid, magnesium stearate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium.

Like all medicines this medicine can cause side effects although not everybody gets them. If you get any of the following serious side effects, contact your doctor straight away or seek emergency help immediately:

Not recommended.

Adults and the elderly: To prevent anaemia, one tablet should be taken daily. To treat anaemia, one tablet should be taken 2 to 3 times a day. Children: Not recommended for children under 6 years or weighing less than 22 kg. Keep out of the sight and reach of children. Each tablet contains 200 mg ferrous sulfate. Also contains sucrose.

If you take more Ferrous Sulfate Tablets than you should

Coating: opaglos (shellac, acetylated monoglyceride, povidone), titanium dioxide (E171), sucrose, calcium carbonate light, acacia, purified talc, Mastercote White SP0962 (titanium dioxide (E171), sugar), wax polish (beeswax, shellac, carnauba wax). See end of section 2 for further information on sucrose.

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include:

• allergic reactions, e.g. skin rashes, swelling of the face, lips, tongue or throat, breathlessness and/or collapse.

5. How to store Ferrous Sulfate Tablets

Keep this medicine out of the sight and reach of children as an overdose may be fatal.

Ferrous sulfate may also cause the following:

• Up to 24 hours: stomach and intestinal poisoning including being sick and diarrhoea, heart disorders such as low blood pressure (hypotension) and a racing heart (tachycardia), metabolic changes such as too much acid in the body (acidosis) and high blood sugar (hyperglycaemia), nervous system depression ranging from tiredness to coma, temporary relief of symptoms may occur.

  Warning: Contains iron. Keep out of the sight and reach of children as overdose may be fatal

Contents of the pack

• Feeling sick (nausea)

  Do not take this medicine after the expiry date shown on the label. The expiry date refers to the last day of that month.

  Ferrous Sulfate Tablets are available in packs of 28, 50, 100, 250, 500 and 1,000. Not all pack sizes may be marketed.

• Being sick (vomiting)

• Gastro-intestinal irritation (Stomach upset)

  Riverside Way, Watchmoor Park, Camberley, GU15 3YL, United Kingdom PL 04416/0216 P

  Sandoz Limited, Park View,

  Ferrous Sulfate Tablets should be stored in a cool dry place.

• Stomach pains

  Larger text version of the leaflet can be made available upon request.

  Marketing authorisation holder and manufacturer

  If you notice any visible signs of deterioration such as broken tablets, take them to your pharmacist for advice before taking them.

• Blackening of stools

  Sandoz Limited, Park View, Riverside Way,

• After 24 hours: stomach and intestinal poisoning and obstruction, shock, too much acid in the body (acidosis), fits, coma, liver failure, jaundice (yellowing of the skin or whites of the eyes), low blood sugar, problems with blood clotting, low production of urine, kidney failure, fluid in the lungs.

• Diarrhoea and constipation (occasionally faecal impaction).

  Watchmoor Park, Camberley, GU15 3YL, United Kingdom

  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.

Not known (frequency cannot be estimated from the available data)

This leaflet was last revised in 10/2018.

Mouth ulceration (in case of incorrect use, when tablets are chewed, sucked or left in the mouth).

ferrous sulfate #200 mg tablets

Base Label