Monopril Plus 20 mg/12.5 mg tablets – fosinopril and hydrochlorothiazide for high blood pressure

Monopril Plus is a tablet with two active substances: fosinopril sodium 20 mg (an ACE inhibitor) and hydrochlorothiazide 12.5 mg (a thiazide diuretic) – ATC C09BA09.

Fosinopril reduces the formation of substances that narrow blood vessels and retain salt and water, while hydrochlorothiazide increases urine output and lowers blood pressure further. Monopril Plus is used to lower high blood pressure when fosinopril alone is not sufficient.

What is Monopril Plus used for and how is it taken correctly?

Key facts about the medicine

What is Monopril Plus used for?

• Lowering high blood pressure (hypertension) in adults when fosinopril alone is not sufficient.

How is Monopril Plus taken and dosed?

• The recommended dose is one tablet a day, at approximately the same time every day.
• The medicine can be taken with or without food.
• If you feel the effect is too strong or too weak, talk to your doctor or pharmacist – do not change the dose yourself.
• Leave at least 2 hours between antacids and Monopril Plus.

Special patient groups

• Children and adolescents under 18: the medicine is not used (efficacy and safety have not been established).
• Kidney impairment: severe impairment (anuria) is a contraindication; in milder cases the doctor monitors kidney function and electrolytes.
• Diabetes: more frequent blood sugar checks may be needed in the first month of treatment.

Contraindications – when the medicine must not be used

• hypersensitivity to fosinopril, other ACE inhibitors, thiazides, sulfonamides or the excipients;
• severe kidney impairment (anuria);
• pregnancy beyond 3 months;
• diabetes or impaired kidney function together with aliskiren;
• current or recent use of sacubitril/valsartan (risk of angioedema).

Warnings and precautions

• Tell your doctor if you have reduced kidney function, narrowing of the renal arteries, liver problems, if you are on haemodialysis or LDL apheresis, if you are dehydrated (diarrhoea, vomiting, strong diuretics, low-salt diet) or are going to have desensitisation to insect stings.
• Hypersensitivity reactions are more common in people with allergies or asthma.
• Skin: if you have had skin cancer or develop an unexpected skin lesion during treatment, contact your doctor; avoid sun and UV radiation.
• Eyes: reduced vision or eye pain (choroidal effusion or increased eye pressure) usually occur within hours to weeks of starting treatment; if untreated they can lead to permanent vision loss. The risk is higher if you have previously been allergic to penicillins or sulfonamides.
• Lungs: tell your doctor if you have previously had lung problems after hydrochlorothiazide; severe shortness of breath after taking the medicine needs urgent help.
• The risk of angioedema is higher with racecadotril, mTOR inhibitors and vildagliptin; very rarely the medicine lowers the white blood cell count.
• Before surgery, anaesthesia or dental procedures, say that you are taking this medicine.
• The medicine contains lactose.

Interactions with other medicines, food and drink

• Potassium: potassium supplements, potassium-containing salt substitutes, potassium-sparing diuretics, trimethoprim, co-trimoxazole, ciclosporin and heparin – tell your doctor.
• Other blood pressure medicines, sartans and aliskiren: additional fall in blood pressure; the doctor adjusts therapy.
• Other: lithium, NSAIDs used regularly and long-term (low-dose acetylsalicylic acid is safe), insulin and oral antidiabetics, calcium salts and vitamin D, barbiturates, morphine, allopurinol, colestyramine and colestipol, mTOR inhibitors.
• Antacids: may reduce the effect – leave at least 2 hours in between.
• Alcohol: may lower blood pressure further.

Pregnancy and breast-feeding

• Pregnancy: not recommended in early pregnancy and must not be used in the second and third trimester because it can cause serious harm to the baby. The doctor will usually advise another treatment before a planned pregnancy or as soon as pregnancy is confirmed.
• Breast-feeding: not recommended, especially if the baby is newborn or premature.

Driving and using machines

• The medicine may occasionally cause dizziness due to an excessive drop in blood pressure, more so at the start of treatment and when the dose is increased – in that case do not drive or operate machinery.

Possible side effects

Common (more than 1 in 100): upper respiratory tract infections, dizziness, headache, cough, muscle and bone pain, tiredness.

Very rare: acute respiratory distress (severe shortness of breath, fever, weakness and confusion).

Frequency not known: pharyngitis, rhinitis, non-melanoma skin and lip cancer, blood cell changes (leukopenia, agranulocytosis, thrombocytopenia, anaemia), low potassium, sodium or chloride, changes in blood sugar, uric acid, magnesium, calcium, cholesterol and lipids, gout, depression, reduced libido, drowsiness, stroke, pins and needles, fainting, visual disturbance, ringing in the ears, irregular heartbeat, angina pectoris, heart attack, low blood pressure and fall in blood pressure on standing, lung inflammation, nausea, vomiting, diarrhoea, inflammation of the stomach, pancreas or liver, jaundice, angioedema, itching, hives and rash, muscle cramps, reduced kidney function, sexual dysfunction, reduced vision or eye pain (choroidal effusion or acute angle-closure glaucoma).

Overdose, missed dose and stopping treatment

• Overdose: may cause a fall in blood pressure with dizziness and fainting. Contact a doctor or the nearest healthcare facility immediately (also if a child has taken the medicine by accident).
• Missed dose: do not take a double dose.
• Stopping treatment: do not stop the medicine without your doctor’s advice – blood pressure may rise.

Related information

Fixed-dose combinations of blood pressure medicines are not intended for starting treatment – the doctor introduces them when one medicine is not enough. Always read the leaflet supplied with the medicine.

For regular home blood pressure monitoring during treatment, see also the Blood pressure monitors category – products in this category do not replace the medicine you have been prescribed.

Composition, pack and manufacturer

• Active substances: fosinopril sodium 20 mg and hydrochlorothiazide 12.5 mg per tablet.
• Excipients: lactose monohydrate; pregelatinised starch; croscarmellose sodium; glycerol dibehenate; lactose monohydrate (Tablettose 80); colour PB-23601 (titanium dioxide E171, lactose, red and yellow iron oxide E172).
• Appearance: round, flat, light orange tablets, 9 mm in diameter, marked “FH”.
• Pack: 2 Alu/Alu blisters of 14 tablets (28 tablets).
• Marketing authorisation holder and manufacturer: PharmaSwiss d.o.o. Belgrade, Batajnički drum 5A, Belgrade.
• Authorisation: 002811588 2024 of 03.09.2025.

Storage

• Store below 25 °C.
• Keep out of the sight and reach of children; do not use after the expiry date.

Frequently asked questions

How does Monopril Plus differ from Monopril?

Monopril contains only fosinopril, while Monopril Plus also contains the diuretic hydrochlorothiazide. The combination is used when fosinopril alone does not lower blood pressure enough.

Why should I protect myself from the sun?

Hydrochlorothiazide, especially long-term at high doses, may increase the risk of some types of skin and lip cancer. The leaflet advises protection from sun and UV rays during treatment.

Can I take calcium and vitamin D?

Only with your doctor’s approval – calcium salts and vitamin D are listed in the leaflet among medicines requiring caution with Monopril Plus.

What if my vision suddenly becomes blurred?

Reduced vision or eye pain may be a sign of fluid build-up in the eye or increased eye pressure. Contact a doctor immediately – without treatment, permanent vision loss can occur.

Sources

• ALIMS – Package leaflet Monopril Plus 20 mg/12.5 mg tablets (PIL, Serbian, 09/2025)
• ALIMS – Summary of product characteristics Monopril Plus (SmPC, Serbian)

Date sources were checked: 25.10.2026.