CETIRIZINE Heumann 10 mg film-coated tablets 50 pc

• 10 mg of cetirizine dihydrochloride

• Lactose-1 water
• Cellulose, microcrystalline
• Hypromellose
• Magnesium stearate (vegetable)
• Silica, finely divided
• Macrogol 400
• Titanium dioxide

CETIRIZINE Heumann Indication / application

• Cetirizine dihydrochloride is the active ingredient of the preparation.
• The medicine is an antiallergic agent.
• In adults and children from 6 years of age, the medicine is indicated for:
  • Relief of nasal and eye symptoms in seasonal and year-round allergic rhinitis.
  • Relief from hives (urticaria).

CETIRIZINE Heumann dosage

• Always take this medicine exactly as described or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Adults and adolescents over 12 years
  • The recommended dose is: 10 mg once a day as 1 tablet
• Children between 6 and 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 daily.
  • If you have severe kidney disease, please talk to your doctor or pharmacist, who will be able to adjust your dose accordingly.
  • If your child has severe kidney disease, please talk to your doctor or pharmacist, who will be able to adjust the dose according to the child's needs.
• If you have the impression that the effect is too weak or too strong, please contact your doctor.

• Duration of ingestion
  • The duration of intake depends on the type, duration and course of your complaints. Please ask your doctor or pharmacist for advice.

• If you take more than you should
  • If you think you have taken an overdose of this medicine, please tell your doctor.
  • Your doctor will then decide what action to take, if any.
  • After an overdose, the side effects described below may occur with increased intensity. Adverse effects such as confusion, diarrhea, dizziness, tiredness, headache, malaise, dilated pupils, itching, restlessness, sedation, drowsiness, drowsiness, increased heart rate, tremors and urinary retention have been reported.

• If you forget to take a dose
  • Do not take a double dose to make up for a forgotten dose.

• If you stop taking it
  • If you stop taking it, in rare cases pruritus (intense itching) and / or urticaria (hives) may return.

• If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

way

• The tablets should be swallowed whole with a glass of liquid.

CETIRIZINE Heumann Side effects

• Like all medicines, this medicine can have side effects, although not everybody gets them.
• The following side effects are rare or very rare. If you experience these side effects, stop taking the medicine immediately and contact your doctor:
  • Allergic reactions, including serious allergic reactions and angioedema (serious allergic reaction causing swelling of the face and throat).
• These reactions can happen soon after you first take the medicine or later.
• Common side effects (affects 1 to 10 users in 100)
  • Somnolence (sleepiness)
  • Dizziness, headache
  • Pharyngitis (inflammation of the throat), rhinitis (runny nose in children)
  • Diarrhea, nausea, dry mouth
  • fatigue
• Uncommon side effects (affects 1 to 10 users in 1,000)
  • excitement
  • Paresthesia (abnormal sensations on the skin)
  • stomach pain
  • Pruritus (itching), rash
  • Asthenia (extreme tiredness), malaise
• Rare side effects (affects 1 to 10 users in 10,000)
  • Allergic reactions, some of them severe (very rare)
  • Depression, hallucination, aggression, confusion, insomnia
  • Convulsions
  • Tachycardia (too fast heartbeat)
  • abnormal liver function
  • Urticaria (itchy rash)
  • Edema (swelling)
  • Weight gain
• Very rare side effects (affects less than 1 in 10,000 people)
  • Thrombocytopenia (low number of blood platelets)
  • Tics (recurring nervous muscle twitches and vocalizations)
  • Syncope (loss of consciousness), dyskinesia (involuntary movements), dystonia (abnormal, persistent, involuntary muscle tension), tremor (shaking), dysgeusia (altered sense of taste)
  • Blurred vision, accommodation disorders (disorders in the near / far adjustment of the eye), oculogyration (uncontrollable circular movement of the eyes)
  • Angioedema (serious allergic reaction causing swelling of the face or throat), fixed drug eruption
  • Abnormal urination (bed-wetting, pain and / or difficulty urinating)
• Not known (frequency cannot be estimated from the available data)
  • Increased appetite
  • Suicidal thoughts (recurring thoughts of suicide or preoccupation with suicide), nightmares
  • Amnesia (loss of memory), impaired memory
  • Vertigo (vertigo)
  • Urinary retention (inability to empty the bladder completely)
  • Pruritus (intense itching) and / or urticaria (hives) when stopping use
  • Joint pain
  • Rash (rash) with blisters that contain pus
  • Hepatitis (inflammation of the liver)
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

CETIRIZINE Heumann Interactions

• Taking with other medicines
  • Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicines.
• Take with food and drink
  • Food does not affect the absorption of cetirizine.

CETIRIZINE Heumann Contraindications

• Do not take the medicine
  • if you have severe kidney disease (severe renal impairment with creatinine clearance below 10 ml / min);
  • if you are allergic to cetirizine, any of the other ingredients of this medicine, to hydroxyzine or to other piperazine derivatives (closely related active substances in other medicines).

CETIRIZINE Heumann pregnancy and breast feeding period

• Ask your doctor for advice before taking this medicine if you are pregnant or breastfeeding, if you suspect you may be pregnant or planning to become pregnant.
• pregnancy
  • Cetirizine should be avoided in pregnant women. Accidental ingestion of the drug by pregnant women should not lead to harmful effects on the fetus. However, the drug should only be taken if necessary and after medical advice.
• Breastfeeding
  • Cetirizine passes into breast milk. Side effects associated with cetirizine may be observed in breast-fed infants. Therefore, until you have contacted your doctor, you should not take cetirizine while breastfeeding.

CETIRIZINE Heumann Patient information

• Warnings and Precautions
  • Talk to your doctor or pharmacist before taking cetirizine.
  • If you suffer from impaired kidney function, please ask your doctor for advice; if necessary, you will take a lower dose. Your doctor will decide the new dose.
  • If you have difficulty urinating (e.g. due to problems with the spinal cord, prostate or urinary bladder), please ask your doctor for advice.
  • If you have epilepsy or are at risk of seizures, please ask your doctor for advice.
  • No clinically meaningful interactions were observed between alcohol (at a blood level of 0.5 per thousand (g / l), equivalent to about a glass of wine) and cetirizine at the recommended dosages. However, there are no safety data when higher doses of cetirizine and alcohol are taken together. Therefore, as with all antihistamines, it is recommended to avoid taking cetirizine and alcohol at the same time.
  • If you are going to have an allergy test, please ask your doctor if you should stop taking cetirizine for a few days before the test, as this medicine could affect the results of an allergy test.
  • children
    • Do not give this medicine to children under 6 years of age as the tablets will not set the required dose.

• Driving and using machines
  • In clinical studies, cetirizine at the recommended dose did not cause any signs of impaired alertness, alertness or ability to drive.
  • If you intend to drive, work without a safe footing, or use machines, you should carefully monitor your reaction to the medicine after taking cetirizine. You should not use more than the recommended dose.