Patient Information Leaflet

Opamid, 1.5 mg, prolonged-release tablets
Indapamide
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. 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 any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

What Opamid is and what it is used for
What you need to know before taking Opamid
How to take Opamid
Possible side effects
How to store Opamid
Contents of the pack and other information

1. What Opamid is and what it is used for

Opamid is a prolonged-release tablet containing indapamide as the active substance.
Opamid is used in the treatment of high blood pressure (hypertension) in adults.
Indapamide is a diuretic medicine. Most diuretics increase the volume of urine produced by the kidneys.
However, indapamide differs from other diuretics in that it causes only a slight increase in urine volume.
In addition, indapamide dilates blood vessels, allowing blood to flow more easily. This helps lower blood pressure.

2. Important information before using Opamid

When not to use Opamid

if the patient is allergic to indapamide, any other sulfonamide, or any of the other ingredients of this medicine (listed in section 6)
if the patient has severe kidney disease
if the patient has severe liver disease
if the patient has a condition called hepatic encephalopathy (a disorder of central nervous system function)
if the patient has low blood potassium levels.

Warnings and precautions
Before starting treatment with Opamid, consult your doctor if:

the patient has impaired liver function
the patient has diabetes
the patient has gout
the patient has cardiac rhythm disorders
the patient has impaired kidney function
the patient is scheduled for parathyroid function testing
the patient experiences visual disturbances or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive accumulation of fluid between choroid and sclera) or increased intraocular pressure, which may occur from several hours to several weeks after taking Opamid. Without treatment, these symptoms may lead to complete loss of vision. If the patient previously had an allergic reaction to penicillin or sulfonamides, they may be at increased risk of developing these symptoms.
if the patient has muscle disorders, including pain, tenderness, weakness, or muscle cramps.

The patient should inform the doctor if they have experienced photosensitivity reactions.
The doctor may recommend blood tests to assess whether sodium and potassium levels are decreased or calcium levels are increased.
If the patient believes any of the above situations apply, or has questions or doubts about using this medicine, they should contact their doctor or pharmacist.

Opamid and other medicines
Tell the doctor or pharmacist about all medicines currently or recently taken, and any medicines the patient plans to take.
Do not take Opamid together with lithium (used to treat depression) due to the risk of increased lithium blood levels.
Inform the doctor if taking any of the following medicines, as special precautions 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 psychiatric 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 causing chest pain)
cisapride, difemanil (used to treat gastrointestinal disorders)
antibiotics used to treat bacterial infections (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin)
intravenous vincamine (used to treat symptomatic cognitive disorders in elderly people, 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 drugs with analgesic effect (e.g. ibuprofen) or high doses of acetylsalicylic acid
angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart failure)
intravenous amphotericin B (an antifungal medicine)
oral corticosteroids, used to treat various diseases including severe asthma and rheumatoid arthritis
stimulant laxatives that increase intestinal peristalsis
baclofen (used to treat muscle stiffness occurring in diseases such as multiple sclerosis)
allopurinol (used to treat gout)
potassium-sparing diuretics (e.g. amiloride, spironolactone, triamterene)
metformin (used to treat diabetes)
iodinated contrast agents (used during radiological examinations)
calcium-containing tablets or other calcium supplements
cyclosporine, tacrolimus, or other immunosuppressive medicines used after organ transplantation or to treat autoimmune diseases, or severe rheumatic or dermatological diseases
tetracosactide (used to treat Crohn's disease)
methadone (used to treat addiction).

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
This medicine is not recommended during pregnancy. If the patient plans pregnancy or pregnancy is confirmed, alternative, more appropriate treatment should be started as soon as possible. The patient should inform the doctor if she is pregnant or planning pregnancy.
Breastfeeding is not recommended while taking this medicine, as the active substance passes into breast milk.

Driving and operating machinery
This medicine may cause adverse effects due to low blood pressure, such as dizziness or fatigue (see section 4). These are more common at the beginning of treatment or after dose increase. If such adverse effects occur, the patient should not drive or perform other activities requiring concentration. However, with appropriate treatment monitoring, such adverse effects are unlikely to occur.

Opamid contains lactose
One extended-release tablet of Opamid contains 144 mg of lactose (monohydrate).
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Opamid

This medicine should always be used as directed by a physician. In case of doubt, consult a
physician or pharmacist.
The usual dose of Opamid is one tablet per day, preferably taken in the morning.
Tablets may be taken regardless of meals. Swallow the tablets whole with water. Do not crush or chew the tablets.
Treatment of hypertension is usually long-term.
Taking a higher than recommended dose of Opamid
If the patient (or another person) accidentally takes a dose higher than recommended, contact a
physician, healthcare center, or go to a hospital immediately.
Taking a very high dose of Opamid may cause nausea, vomiting, hypotension, muscle cramps,
dizziness, drowsiness, disorientation, and changes in urine output.
Missing a dose of Opamid
If the patient forgets to take a dose, take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Opamid
Since treatment of high blood pressure is usually long-term, the patient should consult a physician
before stopping treatment with this medicine.
If you have any further questions regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If any of the following adverse reactions occur in a patient, the medicine should be discontinued immediately and medical advice should be sought without delay:

Angioedema and (or) urticaria. Angioedema is characterized by swelling of the skin of the limbs or face, lips or tongue, or mucous membranes of the throat or airways, causing breathlessness or difficulty swallowing. If such symptoms occur, immediate medical attention is required (Very rare) (may occur in no more than 1 in 10,000 people).
Severe skin reactions, including severe rash, redness of the entire body surface, intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome), or other allergic reactions (Very rare) (may occur in no more than 1 in 10,000 people).
Life-threatening heart rhythm disorders (Frequency unknown).
Pancreatitis, which may cause severe upper abdominal pain radiating to the back and general malaise (Very rare) (may occur in no more than 1 in 10,000 people).
Brain disease caused by liver disorder (Hepatic encephalopathy) (Frequency unknown).
Inflammation of the liver (Frequency unknown).
Muscle weakness, cramps, tenderness or muscle pain, particularly if the patient simultaneously feels unwell or has a high temperature, which may be due to abnormal muscle breakdown (Frequency unknown).

Other adverse reactions, grouped by decreasing frequency:
Common ( may occur in up to 1 in 10 people ):

Low blood potassium levels, which may cause muscle weakness.
Red, raised rash.
Allergic reactions, mainly affecting the skin, in individuals prone to allergies and asthmatic reactions.

Uncommon ( may occur in up to 1 in 100 people ):

Vomiting.
Small red spots on the skin (petechiae).
Low blood sodium levels, which may cause dehydration and low blood pressure.
Impotence (inability to achieve and maintain erection).

Rare ( may occur in up to 1 in 1,000 people ):

Low blood chloride levels.
Low blood magnesium levels.
Feeling tired, headache, tingling and pricking sensations (paresthesia), dizziness.
Gastrointestinal disturbances (such as nausea, constipation), dry mouth.

Very rare ( may occur in up to 1 in 10,000 people ):

Changes in blood cell composition, such as thrombocytopenia (reduced number of platelets, leading to easy bruising and nosebleeds), leukopenia (reduced number of white blood cells, which may cause unexplained fever, sore throat or other flu-like symptoms – if such symptoms occur, medical advice should be sought), and anemia (reduced number of red blood cells).
High blood calcium levels.
Heart rhythm disorders (causing palpitations, awareness of heartbeat), low blood pressure.
Kidney disease (causing fatigue, increased need to urinate, skin itching, nausea, limb swelling).
Abnormal liver function.

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

Fainting.
If the patient has systemic lupus erythematosus (an autoimmune disease leading to inflammation and damage of joints, tendons, and internal organs, causing symptoms such as rash, fatigue, loss of appetite, weight loss, and joint pain), use of this medicine may worsen the disease.
Cases of photosensitivity reactions (skin changes) following exposure to sunlight or artificial UVA radiation have also been reported.
Myopia.
Blurred vision.
Visual disturbances.
Visual impairment or eye pain due to increased intraocular pressure (possible symptoms of fluid accumulation in the vascular membrane surrounding the eye – excessive fluid buildup between the choroid and sclera – or acute angle-closure glaucoma).
Laboratory test results may change, and the doctor may recommend periodic blood tests. These changes include: increased uric acid levels, a substance which may cause or worsen gout (joint pain, especially in the feet); increased blood glucose levels in patients with diabetes; increased liver enzyme activity.
Abnormal ECG findings.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Opamid

This medicine does not require special storage conditions.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton after EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This practice will help protect the environment.

6. Contents of the pack and other information

What Opamid contains

The active substance is indapamide. Each prolonged-release tablet contains 1.5 mg of indapamide.
The other ingredients in the tablet core are: lactose monohydrate, maize starch, pregelatinized, hypromellose (E 464), colloidal anhydrous silica (E 551), magnesium stearate (E 470 B).
The other ingredients in 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.
Pack sizes: 30, 60, 90 tablets in PVC/aluminium blister packs.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Czech Republic, Finland, Slovakia: Indapamide Orion
Poland: Opamid