Obsidan

Package Leaflet: Information for the User

Obsidan, 100 mg, Gastro-Resistant Capsules, Hard

Ferrous Sulphate Heptahydrate

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• 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 you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Obsidan and what is it used for
• 2. Important information before taking Obsidan
• 3. How to take Obsidan
• 4. Possible side effects
• 5. How to store Obsidan
• 6. Contents of the pack and other information

1. What is Obsidan and what is it used for

Obsidan is an oral iron supplement used to treat or prevent iron deficiency. Iron is essential for transporting oxygen and energy in the body. These capsules are designed to be gastro-resistant, meaning they do not release their contents in the stomach. They transport iron to the intestines, where it is absorbed.

Obsidan is used to treat iron deficiency.

2. Important information before taking Obsidan

When not to take Obsidan

Children

• Children under 6 years of age must not take Obsidan.
• Children from 6 years of age with a body weight below 20 kg must not take Obsidan.

Warnings and precautions

Before starting to take Obsidan, discuss it with your doctor or pharmacist.

While taking Obsidan, be particularly careful:

• Your teeth may become discoloured while taking Obsidan. (This discolouration may disappear after stopping Obsidan. If it persists, it can be removed with a whitening toothpaste or professional dental cleaning).

Children

Particular care should be taken when administering Obsidan to children, as overdose can lead to poisoning.

Obsidan and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.

Increased efficacy and possible enhancement of side effects

• Painkillers and anti-rheumatic drugs (e.g. salicylates and phenylbutazone): may enhance stomach mucosa irritation caused by Obsidan.
• Intravenous iron administration combined with oral iron therapy may lead to decreased blood pressure (hypotension) and even shock due to rapid release of iron and possible overdose. This combination is not recommended.

Decreased efficacy and possible enhancement of side effects

• Certain antibiotics (tetracyclines) or drugs (bisphosphonates) used to treat weakened bone structure (osteoporosis): if you are also taking Obsidan, both iron and tetracycline or bisphosphonate absorption are limited. This means the efficacy of these drugs will be reduced. You should ask your doctor if it is necessary to increase the dose of these drugs.
• Drugs containing calcium, magnesium or aluminium, e.g. antacids, calcium and magnesium salts used as substitutes: these drugs reduce or prevent iron absorption from Obsidan. It may be necessary to increase the dose of Obsidan.
• Drugs used for arthritis, such as penicillamine and oral gold compounds, drugs used for Parkinson's disease, such as methyldopa and levodopa, and thyroxine, used to treat hypothyroidism: these drugs are less well absorbed when taken with Obsidan. You should ask your doctor if it is necessary to increase the dose of these drugs.
• Antibiotics belonging to the fluoroquinolone group, e.g. ciprofloxacin, levofloxacin, norfloxacin and ofloxacin: iron significantly reduces the absorption of these drugs. Before starting to take these drugs, you should inform your doctor that you are taking Obsidan.

The time interval between taking Obsidan and any of the above-mentioned drugs should be at least two hours.

The time interval between taking Obsidan and tetracycline (other than doxycycline, see below) should be at least three hours.

• Doxycycline and Obsidan should not be taken together, as doxycycline may inhibit the absorption and distribution of Obsidan.

Other possible side effects

• Obsidan may cause darkening of the stool, which does not result from hidden gastrointestinal bleeding.
• Obsidan contains vitamin C, which may cause false-negative results in common stool tests for occult blood.

Obsidan with food and drink

Obsidan should not be taken during meals. Substances contained in plant products (e.g. cereals and vegetables) may form complexes with iron (e.g. phytates, oxalates and phosphates).

These complexes cause retention of iron absorption. Components of coffee, tea, milk and cola may also reduce iron absorption into the blood.

The time interval between taking these foods and Obsidan should be at least two hours.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

No risks have been identified with the use of Obsidan during pregnancy and breastfeeding.

Driving and using machines

It is unlikely that Obsidan will affect your ability to drive or use machines.

Obsidan contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially 'sodium-free'.

3. How to take Obsidan

This medicine should always be taken exactly as described in this leaflet or as directed by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist.

Do not take more than 5 mg of Obsidan per kilogram of body weight. For example, if you weigh 60 kg, the maximum daily dose will be 5 x 60 = 300 mg (three capsules).

If your doctor does not prescribe otherwise, the typical dose is:

Children from 6 years of age (minimum body weight – 20 kg), adolescents and adults

Adolescents from 15 years of age (minimum body weight – 50 kg) and adults

In the case of adolescents from 15 years of age and adults with significant iron deficiency, the following dosing is recommended at the beginning of treatment:

Use in children and adolescents

Obsidan must not be used in children under 6 years of age (with a body weight below 20 kg) (see section 2).

Children from 6 years of age (with a minimum body weight of 20 kg) can be given 1 capsule per day.

More information on dosing can be found in the table.

Method of administration

Obsidan capsules should be taken with a sufficient amount of water, DO NOT CHEW THE CAPSULE. Capsules should be taken at an appropriate interval from meals (e.g. in the morning on an empty stomach or between two main meals), as food components may reduce absorption.

Note

If you cannot swallow the capsule or do not want to swallow it, you can empty the capsule and swallow its contents. To do this, carefully pull the two halves of the capsule apart over a bowl. Gently shake out the contents, scoop them out with a teaspoon and swallow. After swallowing the capsule contents, drink some water.

Duration of treatment

Your doctor will decide how long you should take Obsidan.

Treatment should be continued until normal iron levels are achieved in the blood, which usually takes from 10 to 20 weeks or longer in the case of chronic underlying disease.

The duration of treatment for the prevention of iron deficiency depends on the situation (pregnancy, blood donation, long-term haemodialysis and planned autotransfusion – a procedure where the recipient and donor are the same person).

Taking a higher dose of Obsidan than recommended

After intentional or accidental overdose, symptoms described in section 4 "Possible side effects" may occur and will be more severe.

If you take more Obsidan than you should, inform your doctor immediately.

Overdose can cause poisoning, especially in children.

Iron poisoning can cause symptoms such as: restlessness, abdominal pain, nausea, vomiting and diarrhoea. The stool becomes tar-like, and vomit may contain blood.

Shock, acidosis (disturbed acid-base balance, excessive amount of acids in the body) and coma may occur. After the onset of convulsions, Cheyne-Stokes respiration (abnormal breathing pattern, characterized by alternating periods of shallow and deep breathing), coma and pulmonary oedema, death may occur.

Missing a dose of Obsidan

Do not take a double dose to make up for a forgotten dose. If you forget to take one or more doses of Obsidan, you should take it for a bit longer.

Stopping Obsidan treatment

No special precautions are required before stopping Obsidan treatment.

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

4. Possible side effects

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

Obsidan may, in rare cases (whose frequency cannot be estimated from the available data), cause a severe allergic reaction (anaphylactic reaction).

In case of serious rash, itching and difficulty breathing, consult a doctor immediately.

Common side effects (occurring in 1 to 10 in 100 patients):

• discomfort in the stomach or intestines (in the abdominal cavity);
• heartburn;
• vomiting;
• loose stools (diarrhoea);
• nausea;
• constipation;
• stool (faeces) with dark colour.

Rare side effects (occurring in 1 to 10 in 10,000 patients):

• tooth discolouration (see also special precautions for use of Obsidan in section 2);
• hypersensitivity (e.g. skin hypersensitivity symptoms, exanthema, rash, urticaria).

Unknown (frequency cannot be estimated from the available data):

• abdominal pain and epigastric pain;
• gastrointestinal bleeding;
• change in tongue colour;
• change in colour of the oral cavity.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.

Side effects can be reported directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181C,

02-222 Warsaw,

Tel.: + 48 22 49 21 301,

Fax: + 48 22 49 21 309,

Website: https://smz.ezdrowie.gov.pl.

By reporting side effects, you can help provide more information on the safety of this medicine.

Side effects can also be reported to the marketing authorisation holder.

5. How to store Obsidan

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

Do not use this medicine after the expiry date stated on the outer packaging and blister.

The expiry date refers to the last day of the month.

Do not store above 25°C.

6. Contents of the pack and other information

What Obsidan contains

• The active substance is iron(II) sulphate pentahydrate complex with glycine. One capsule contains: 567.7 mg of iron(II) sulphate pentahydrate complex with glycine, equivalent to 100 mg of iron ions (Fe).
• The other ingredients are: Granules containing iron(II) sulphate pentahydrate complex with glycine: ascorbic acid, microcrystalline cellulose, hypromellose, hydroxypropylcellulose, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion (Eudragit L30 D 55) (contains methacrylic acid and ethyl acrylate copolymer (1:1), sodium lauryl sulphate, polysorbate 80), acetylated triethyl citrate, talc. Capsule:
• body: gelatin, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172);
• lid: gelatin, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172).

What Obsidan looks like and contents of the pack

Obsidan is a hard gastro-resistant capsule with a size of approximately 21.7 mm x 7.5 mm with a chestnut-brown opaque lid without imprint and an orange opaque body without imprint.

It contains grey-brown powder-coated, gastro-resistant granules.

Obsidan is available in packs of 30, 50, 90, 100 or 500 gastro-resistant hard capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder

VEDIM sp. z o.o.

ul. Kruczkowskiego 8

00-380 Warsaw

Tel.: + 48 22 696 99 20

Manufacturer

Aesica Pharmaceuticals GmbH

Alfred-Nobel-Str. 10

40789 Monheim am Rhein

Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Denmark: Niferex

Spain: Ferro Sanol

Greece: Ferro Sanol Duodenal

Italy: Niferex

Norway: Niferex

Poland: Obsidan

Portugal: Ferbisol

Sweden: Niferex

Date of last revision of the leaflet:April 2023