Opamid

Leaflet attached to the packaging: patient information

Opamid, 1.5 mg, prolonged-release tablets

Indapamide

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any further doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Opamid and what is it used for

Opamid is a prolonged-release tablet containing indapamide as the active substance. Opamid is used to treat high blood pressure in adults.

Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys.

However, indapamide differs from other diuretics as it causes only a slight increase in urine production.

In addition, indapamide dilates blood vessels, making it easier for blood to flow through them.

This helps to lower blood pressure.

2. Important information before taking Opamid

When not to take Opamid

• if you are allergic to indapamide, any other sulfonamide, or any of the other ingredients of this medicine (listed in section 6)
• if you have severe kidney disease
• if you have severe liver disease
• if you have a condition called hepatic encephalopathy (a brain disorder caused by liver disease)
• if you have low potassium levels in your blood.

Warnings and precautions

Before starting to take Opamid, you should discuss it with your doctor if:

• you have liver function disorders
• you have diabetes
• you have gout
• you have heart rhythm disorders
• you have kidney function disorders
• you are scheduled to undergo a parathyroid function test
• you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure, which can occur within a few hours to a few weeks after taking Opamid. Without treatment, symptoms can lead to complete vision loss. If you have previously been allergic to penicillin or sulfonamides, you may be at increased risk of developing these symptoms.
• you have muscle disorders, including pain, tenderness, weakness, or muscle cramps.

You should inform your doctor if you have had allergic reactions to light.

Your doctor may recommend blood tests to assess whether your sodium and potassium levels are not decreased or whether your calcium levels are increased.

If you think any of the above situations apply to you, or if you have any questions or doubts about taking the medicine, you should contact your doctor or pharmacist.

Opamid and other medicines

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

You should not take Opamid at the same time as lithium (used to treat depression) due to the risk of increased lithium levels in the blood.

You should inform your doctor about taking any of the following medicines, as special caution may be necessary:

• medicines used to treat heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis preparations, bretylium)
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, antipsychotics, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol))
• bepridil (used to treat angina pectoris, a condition that causes chest pain)
• cisapride, difemanil (used to treat gastrointestinal disorders)
• antibiotics used to treat bacterial infections (e.g., sparfloxacin, moxifloxacin, erythromycin given by injection)
• vincamine given by injection (used to treat symptomatic cognitive disorders in the elderly, including memory loss)
• halofantrine (an antiparasitic medicine used to treat certain types of malaria)
• pentamidine (used to treat certain types of pneumonia)
• antihistamines used to treat allergic reactions, such as hay fever (e.g., mizolastine, astemizole, terfenadine)
• non-steroidal anti-inflammatory medicines with analgesic effects (e.g., ibuprofen) or high doses of acetylsalicylic acid
• angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart failure)
• amphotericin B given by injection (an antifungal medicine)
• orally administered corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis
• laxatives that stimulate intestinal peristalsis
• baclofen (used to treat muscle stiffness, such as in multiple sclerosis)
• allopurinol (used to treat gout)
• potassium-sparing diuretics (e.g., amiloride, spironolactone, triamterene)
• metformin (used to treat diabetes)
• iodine-based contrast agents (used during radiological examinations)
• calcium-containing tablets or other calcium supplements
• cyclosporine, tacrolimus, or other medicines that suppress the immune system after organ transplantation or used to treat autoimmune diseases, severe rheumatic diseases, or dermatological diseases
• tetracosactide (used to treat Crohn's disease)
• methadone (used to treat addiction).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

The medicine is not recommended during pregnancy. If you plan to become pregnant or when pregnancy is confirmed, you should start another, more suitable treatment method as soon as possible. You should inform your doctor if you are pregnant or plan to become pregnant.

Breastfeeding is not recommended while taking this medicine, as the active substance passes into breast milk.

Driving and using machines

The medicine may cause side effects due to low blood pressure, such as dizziness or fatigue (see section 4). These occur more frequently at the beginning of treatment or after increasing the dose. If side effects occur, you should not drive or operate machinery. However, with proper control of treatment, such side effects should not occur.

Opamid contains lactose

One prolonged-release tablet of Opamid contains 144 mg of lactose (monohydrate). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Opamid

This medicine should always be taken according to your doctor's recommendations. In case of doubts, you should consult your doctor or pharmacist.

The usual dose of Opamid is one tablet per day, taken preferably in the morning. The tablets can be taken with or without food. The tablets should be swallowed whole with water. The tablets should not be crushed or chewed.

Treatment of high blood pressure is usually long-term.

Taking a higher dose of Opamid than recommended

In case of accidental ingestion of a higher dose than recommended, you should immediately contact your doctor, a healthcare center, or go to the hospital.

Taking a very high dose of Opamid may cause nausea (vomiting), vomiting, low blood pressure, muscle cramps, dizziness, drowsiness, disorientation, and changes in urine output.

Missing a dose of Opamid

If you forget to take a dose, you should take the next dose at the usual time. You should not take a double dose to make up for the missed dose.

Stopping treatment with Opamid

Since treatment of high blood pressure is usually long-term, you should consult your doctor if you plan to stop treatment with this medicine.

In case of any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects, you should stop taking the medicine and contact your doctor immediately:

• angioedema and (or) urticaria. Angioedema is characterized by swelling of the skin of the limbs or face, lips or tongue, mucous membranes of the throat or respiratory tract, causing shortness of breath or difficulty swallowing. If such symptoms occur, you should immediately consult a doctor (very rare) (may occur in fewer than 1 in 10,000 people).
• severe skin reactions, including severe rash, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, mucous membrane inflammation (Stevens-Johnson syndrome) or other allergic reactions (very rare) (may occur in fewer than 1 in 10,000 people)
• life-threatening heart rhythm disorders (frequency not known)
• pancreatitis, which can cause severe abdominal pain radiating to the back and very poor general condition (very rare) (may occur in fewer than 1 in 10,000 people)
• liver disease caused by liver disease (hepatic encephalopathy) (frequency not known)
• liver inflammation (frequency not known)
• muscle weakness, cramps, tenderness, or pain, especially if you feel unwell or have a high temperature, which can be caused by abnormal muscle breakdown (frequency not known).

Other side effects, grouped by decreasing frequency:

• frequent (may occur in fewer than 1 in 10 people):

low potassium levels in the blood, which can cause muscle weakness

• red, raised rash
• allergic reactions, mainly affecting the skin, in people prone to allergies and asthmatic reactions.

infrequent (may occur in fewer than 1 in 100 people):

• vomiting
• red spots on the skin (petechiae)
• low sodium levels in the blood, which can cause dehydration and low blood pressure
• impotence (inability to achieve or maintain an erection).

rare (may occur in fewer than 1 in 1,000 people):

• low chloride levels in the blood
• low magnesium levels in the blood
• feeling of tiredness, headaches, tingling, and numbness (paresthesia), dizziness
• gastrointestinal disorders (such as nausea, constipation), dry mouth.

very rare (may occur in fewer than 1 in 10,000 people):

• changes in blood cell counts, such as thrombocytopenia (decreased platelet count, causing easy bruising and nosebleeds), leukopenia (decreased white blood cell count, causing unexplained fever, sore throat, or flu-like symptoms – if such symptoms occur, you should contact your doctor), and anemia (decreased red blood cell count)

high calcium levels in the blood

• heart rhythm disorders (causing palpitations, feeling of heartbeat), low blood pressure
• kidney disease (causing feeling of tiredness, need to urinate more frequently, itching, nausea, swelling of limbs)
• abnormal liver function.

unknown (frequency cannot be estimated from available data):

• fainting
• if you have systemic lupus erythematosus (an autoimmune disease that causes inflammation and damage to joints, tendons, and internal organs, causing symptoms such as rash, fatigue, loss of appetite, weight loss, and joint pain), taking this medicine may worsen the disease
• there have also been reports of hypersensitivity reactions to light (skin changes) after exposure to sunlight or artificial UVA radiation
• myopia
• blurred vision
• vision disorders
• vision loss or eye pain due to increased intraocular pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye – excessive fluid accumulation between the choroid and sclera – or acute angle-closure glaucoma)
• there may be changes in laboratory test results, and your doctor may recommend control blood tests. These changes include: increased uric acid levels, a substance that can cause or worsen gout (joint pain, especially in the feet); increased glucose levels in the blood in patients with diabetes; increased liver enzyme activity
• abnormal ECG recording.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl

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

Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Opamid

This medicine does not require special storage conditions.

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Opamid contains

• The active substance of Opamid is indapamide. Each prolonged-release tablet contains 1.5 mg of indapamide.
• The other ingredients of the tablet core are: lactose monohydrate, cornstarch, pre-gelatinized, hypromellose (E 464), colloidal silica anhydrous (E 551), magnesium stearate (E 470 B).
• The other ingredients of the tablet coating are: hypromellose (E 464), macrogol 6000, titanium dioxide (E 171).

What Opamid looks like and contents of the pack

White or almost white, round, biconvex, film-coated tablets.

The pack contains: 30, 60, 90 tablets in PVC/aluminum blisters.

Not all pack sizes may be marketed.

Marketing authorization holder:

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer:

Orion Corporation, Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

To obtain more detailed information on this medicine, you should contact the local representative of the marketing authorization holder:

Orion Pharma Poland Sp. z o.o.

[email protected]

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

Czech Republic, Finland, Slovakia:

Indapamide Orion

Poland:

Opamid

Date of last revision of the leaflet:13.06.2023