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Clarinase 5 mg/120 mg prolonged-release tablets – loratadine and pseudoephedrine for hay fever with a blocked nose
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- Stock: Zabrana online prodaje
- Brand: BAYER products
- Model: BR-60516288
Clarinase contains a combination of two active substances: loratadine (5 mg), an antihistamine that blocks the effect of histamine released during an allergy, and pseudoephedrine sulfate (120 mg), a decongestant that reduces nasal congestion. The tablet releases the substances gradually (prolonged release).
In Serbia it is registered as a 5 mg/120 mg prolonged-release tablet (marketing authorisation holder Bayer d.o.o. Beograd) and is available on prescription only. Because of pseudoephedrine, the medicine has numerous contraindications – especially in heart disease and high blood pressure.
Important warning
- Supply status: prescription-only medicine.
- It must not be used in very high or uncontrolled blood pressure, heart and blood vessel disease, previous stroke, glaucoma, difficulty urinating, overactive thyroid and severe kidney disease, or with medicines for the heart or blood pressure and MAO inhibitors.
- Stop the medicine immediately and seek emergency help in case of sudden severe headache, vomiting, confusion or visual changes (possible PRES/RCVS), sudden loss of vision, or sudden abdominal pain and rectal bleeding.
- Do not take the medicine for more than 10 days without medical advice; it is not intended for children under 12.
- Athletes may test positive in doping tests.
- This page is for information only and is not an offer to buy the medicine online.
What is Clarinase used for and how is it taken safely?
Key facts about the medicine
| Name of the medicine | Clarinase®, 5 mg/120 mg, prolonged-release tablets |
|---|---|
| Active substances | loratadine; pseudoephedrine sulfate |
| Strength | 5 mg loratadine and 120 mg pseudoephedrine sulfate per tablet |
| Pharmaceutical form | prolonged-release tablet (round, white, coated) |
| Therapeutic group | nasal preparations – sympathomimetics for systemic use, combinations (ATC R01BA52) |
| Pack | 1 Al/Al blister of 10 tablets |
| Marketing authorisation holder / manufacturer | BAYER D.O.O. BEOGRAD; manufacturer SAG Manufacturing S.L.U., Spain |
| ALIMS authorisation number | 000476347 2023 of 28.02.2025 |
| Supply status in Serbia | R – prescription-only medicine |
What is Clarinase used for?
Clarinase relieves the symptoms of seasonal allergic rhinitis (hay fever) – sneezing, runny or itchy nose, watery and itchy eyes – when accompanied by a blocked nose (nasal congestion), in adults and children over 12 years.
Loratadine acts on the allergy symptoms, while pseudoephedrine helps to clear the blocked nose.
How is it taken and dosed?
- Adults and children over 12 years: one tablet twice daily with a glass of water, with or without food.
- Swallow the tablet whole – do not crush, break or chew it, as it is designed to release the medicine gradually.
- Do not take the medicine more often or in a higher dose than recommended.
- Do not take the medicine for more than 10 days unless your doctor recommends it.
This is the dosing from the leaflet – your doctor decides whether the medicine is suitable for you and how long you take it.
Special patient groups
- Children under 12 years: the medicine is not intended for them.
- People aged 60 and over: may be more sensitive to the medicine – ask your doctor.
- Kidney disease: must not be used in severe acute or chronic kidney disease or kidney failure; caution with other kidney, liver or bladder problems.
- Diabetes: ask your doctor before use.
- Intolerance to some sugars: the medicine contains lactose and sucrose.
Contraindications – when the medicine must not be used
- allergy to loratadine, pseudoephedrine or any of the excipients;
- concomitant use of medicines for the heart or blood pressure;
- glaucoma (raised eye pressure), difficulty urinating or urinary tract obstruction;
- very high or uncontrolled blood pressure, heart or blood vessel disease, history of stroke;
- overactive thyroid gland;
- use of MAO inhibitors or stopping them within the last 14 days;
- severe acute or chronic kidney disease or kidney failure.
Warnings and precautions
- Ask your doctor if you have diabetes, narrowing of the stomach, small intestine or oesophagus due to an ulcer, pyloroduodenal obstruction, bladder neck obstruction, a history of bronchospasm, or liver, kidney or bladder problems.
- Before planned surgery the medicine may need to be stopped for a few days.
- Tell your doctor if you have high blood pressure, a fast or pounding heartbeat, irregular heart rhythm, nausea and headache, or worsening headache during treatment.
- Pseudoephedrine can be misused; high doses can be toxic.
- Widespread skin redness with pus-filled blisters and fever (AGEP) requires stopping the medicine and contacting the doctor.
- Ischaemic colitis (sudden abdominal pain, rectal bleeding) and reduced blood flow to the optic nerve (sudden loss of vision) may occur – stop the medicine immediately.
- PRES and RCVS – rare disorders involving reduced blood supply to the brain – have been reported.
- Stop the medicine 2 days before skin allergy tests.
- Athletes may test positive in doping tests.
Interactions with other medicines, food and drink
- Contraindicated: medicines for the heart or blood pressure, MAO inhibitors (and for 14 days after stopping them).
- Tell your doctor if you take: digitalis; methyldopa, mecamylamine, reserpine or guanethidine (dose adjustment may be needed).
- Increased blood pressure is possible with other decongestants (oral or nasal), appetite suppressants (slimming pills), amphetamines, ergot alkaloids for migraine (dihydroergotamine, ergotamine, methylergometrine), linezolid, bromocriptine, cabergoline, lisuride and pergolide.
- Clarinase has not been shown to increase the effect of alcohol.
- Tell your doctor about all medicines you take, including those available without a prescription.
Pregnancy and breast-feeding
Do not use Clarinase if you are pregnant. The medicine must not be taken while breast-feeding – loratadine and pseudoephedrine pass into breast milk, and reduced milk production has been reported with pseudoephedrine.
Driving and using machines
At the recommended dose, drowsiness or reduced alertness is not expected. Very rarely drowsiness may still occur, which may affect the ability to drive or use machines.
Possible side effects
- Very common: insomnia.
- Common: thirst, nervousness, drowsiness, depression, agitation, loss of appetite, dizziness, dry mouth, fast heartbeat, sore throat and inflamed nasal lining, constipation, nausea, headache, tiredness.
- Uncommon: confusion, tremor, increased sweating, hot flushes, altered taste, watery eyes, ringing in the ears, palpitations, nosebleed, frequent or abnormal urination, itching.
- Very rare: serious allergic reactions (rash, hives, facial swelling), convulsions, irregular heart rhythm, high blood pressure, cough, narrowing of the airways, liver problems, difficulty urinating, hair loss.
- Not known: PRES and RCVS, AGEP, ischaemic colitis, ischaemic optic neuropathy, weight gain.
Report suspected side effects to your doctor, pharmacist or ALIMS.
Overdose, missed dose and stopping treatment
- Overdose: contact your doctor or pharmacist immediately. Drowsiness, fast heartbeat and headache have been reported with loratadine overdose, and convulsions, fast heartbeat, nausea and nervousness with pseudoephedrine overdose.
- Missed dose: take it as soon as possible, then continue as usual. Do not take a double dose.
- Duration: no longer than 10 days without medical advice.
When to seek medical help immediately?
- sudden severe headache, weakness, vomiting, confusion or changes in the visual field (possible PRES/RCVS)
- sudden loss of vision
- sudden abdominal pain or rectal bleeding
- fever with skin redness and many small pus-filled blisters (AGEP), especially in the first two days
- facial swelling, rash and difficulty breathing (severe allergic reaction)
- strong pounding or irregular heartbeat, convulsions
Pharmacist's advice
Before starting Clarinase, tell your doctor or pharmacist whether you have high blood pressure, heart disease, glaucoma, prostate or urination problems or thyroid disease, and which medicines you take – many medicines for blood pressure, the heart and migraine must not be combined with pseudoephedrine. If you have a blood pressure monitor, check your blood pressure occasionally during treatment.
Take the tablets twice daily, about 12 hours apart; because insomnia is possible, do not take the second dose late in the evening if it disturbs your sleep. Do not use decongestant nasal sprays (e.g. xylometazoline, oxymetazoline) at the same time – use sea water or saline to moisturise and rinse the nose.
Availability and price
Clarinase is supplied on prescription only and cannot be ordered online – this page is for information only.
Please check availability and supply conditions at a pharmacy with a valid prescription.
Related information
For additional care and support for a blocked nose, see also the Clogged nose category – products in this category do not replace the medicine you have been prescribed.
Composition, pack and manufacturer
- Active substances: loratadine 5 mg and pseudoephedrine sulfate 120 mg per prolonged-release tablet.
- Excipients – core: lactose monohydrate; maize starch; povidone; magnesium stearate. Coating: sucrose; calcium sulfate (anhydrous and dihydrate); talc; rosin; acacia; zein; titanium dioxide; oleic acid; powdered soap; microcrystalline cellulose; carnauba wax; white beeswax.
- Appearance: round, biconvex, glossy, white coated tablets.
- Pack: Al/Al blister with desiccant, 10 tablets in a carton.
- Marketing authorisation holder: BAYER D.O.O. BEOGRAD, Omladinskih brigada 88b, Belgrade. Manufacturer: SAG Manufacturing S.L.U., San Agustin de Guadalix, Madrid, Spain.
Storage
- Store below 25 °C in the original package to protect from moisture. Do not freeze.
- Shelf life: 2 years (SmPC).
- Keep out of the sight and reach of children.
Frequently asked questions
How is Clarinase different from a medicine containing only loratadine?
In addition to the antihistamine loratadine, Clarinase contains pseudoephedrine, which reduces nasal congestion. Because of pseudoephedrine it is prescription-only and has more contraindications (heart, blood pressure, glaucoma, urination, thyroid).
How long can I take Clarinase?
Unless your doctor recommends otherwise, no longer than 10 days, one tablet twice daily.
Can I take Clarinase if I have high blood pressure?
In very high or uncontrolled blood pressure, heart disease and with blood pressure medicines it must not be used. In any case, tell your doctor about high blood pressure before use.
Can I split the tablet in half?
No – the tablet is swallowed whole, without crushing, breaking or chewing, because it is a prolonged-release tablet.
Sources
- ALIMS – Summary of Product Characteristics Clarinase®, 5 mg/120 mg, prolonged-release tablets (Serbian)
- ALIMS – Patient leaflet Clarinase®, 5 mg/120 mg, prolonged-release tablets (February 2025, Serbian)
Sources checked on: 24 October 2026.
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