Cetirizine ratiopharm 10 mg film-coated tablets

Cetirizine dihydrochloride is the active ingredient in Cetirizine ratiopharm.
Cetirizine ratiopharm is an antiallergic.

In adults and children from 6 years of age, Cetirizine ratiopharm is indicated for:

• Relief of nasal and ocular symptoms in seasonal and perennial allergic rhinitis (inflammation of the lining of the nose).
• Relief of chronic hives (chronic idiopathic urticaria).

If you do not feel better or if you feel worse after 3 days, contact your doctor.

Contraindications

Do not take Cetirizine ratiopharm

• if you are allergic to cetirizine, any of the other ingredients (listed in section 6), to hydroxyzine or to other piperazine derivatives (closely related active ingredients of other medicines).
• if you have severe kidney disease (severe renal impairment with creatinine clearance below 10 ml/min).

interactions

Other medicines and Cetirizine ratiopharm
Please tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take any other medicines, including those obtained without a prescription.

Taking Cetirizine ratiopharm with food and drink
Food does not affect the absorption of Cetirizine ratiopharm.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy
Cetirizine ratiopharm should be avoided in pregnant women. Accidental ingestion of the drug by pregnant women should not result in any harmful effects on the fetus. Nevertheless, the drug should only be taken when necessary and as directed by a doctor.

Breast- feeding
Cetirizine is excreted in breast milk. Therefore, you should not take Cetirizine ratiopharm if you are breast-feeding until you have consulted your doctor.

Driving and using machines
In clinical trials, Cetirizine ratiopharm at the recommended dose did not produce any signs of impairment in alertness, alertness or the ability to drive.
If you intend to drive, work unstable or use machines, you should carefully monitor how you react to the medicine after taking Cetirizin ratiopharm. You should not use more than the recommended dose.

application

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How and when should you take Cetirizine ratiopharm?
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed whole with a glass of liquid.
The tablet can be divided into equal doses.

Adults and adolescents over 12 years of age
The recommended dose is 10 mg once a day as 1 tablet.

Children aged 6 to 12 years
The recommended dose is 5 mg twice a day as half a tablet twice a day.

Patients with kidney failure
Patients with moderate kidney failure are recommended to take 5 mg once a day.
If you have severe kidney disease, talk to your doctor or pharmacist who can adjust your dose accordingly.
If your child has severe kidney disease, talk to your doctor or pharmacist who can adjust the dose according to your child's needs.

If you have the impression that the effect of Cetirizine ratiopharm is too weak or too strong, please contact your doctor.

Duration of intake
The duration of intake depends on the type, duration and course of your symptoms and will be determined by your doctor.

side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The following side effects are rare or very rare. If you notice any of these side effects, you must stop taking the medicine immediately and contact your doctor:

• Allergic reactions, including severe reactions and angioedema (severe allergic reaction causing swelling of the face or throat)

These reactions can start very soon after the first use of the drug or later.

Common side effects (may affect up to 1 in 10 people)

• sleepiness
• dizziness, headache
• Throat catarrh, nasal catarrh (in children)
• diarrhea, nausea, dry mouth
• exhaustion

Uncommon side effects (may affect up to 1 in 100 people)

• restlessness
• paresthesia (unusual skin sensations)
• stomach pain
• itching, rash
• Asthenia (extreme fatigue), malaise

Rare side effects (may affect up to 1 in 1,000 people)

• Allergic reactions, some severe (very rare)
• Depression, hallucination, aggression, confusion, sleep disturbance
• cramps
• Tachycardia (heart beating too fast)
• abnormal liver function
• hives
• edema (swelling)
• weight gain

Very rare side effects (may affect up to 1 in 10,000 people)

• thrombocytopenia (reduced number of platelets in the blood)
• Tics (recurrent, nervous muscle twitches and vocalizations)
• Fainting, dyskinesia (involuntary movements), dystonia (abnormally prolonged muscle contractions), tremor, dysgeusia (altered sense of taste)
• Blurred vision, accommodation disorder (disorders in how the eye adjusts for near/far distance), oculogyration (uncontrollable circular movement of the eyes)
• Angioedema (severe allergic reaction causing swelling of the face or throat), fixed drug eruption
• abnormal urination (bedwetting, pain and/or difficulty urinating)

Not known (cannot be estimated from the available data)

• Increased appetite
• Suicidal thoughts (recurring thoughts or preoccupation with suicide)
• memory loss, memory disorders
• dizziness (sensation of spinning or moving)
• urinary retention (inability to completely empty the bladder)
• Pruritus (severe itching) and/or urticaria (hives) when stopping treatment
• joint pain
• rash with blisters containing pus
• hepatitis (inflammation of the liver)

composition

The active substance is cetirizine dihydrochloride.
1 film-coated tablet contains 10 mg cetirizine dihydrochloride.

The other ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, titanium dioxide (E171), hypromellose 5cP (E464), macrogol 400.