RHIZIN

What is in this leaflet?

1. What Rhizin is and what it is used for.

2. What you need to know before you take Rhizin.

3. How to take Rhizin.

4 Possible side effects.

5. How to store Rhizin.

6. Contents of the pack and other information.

1. What Rhizin is and what it is used for

The active ingredient (which makes this medicine work is called cetirizine hydrochloride, which belongs to a family of medicines called antihistamine Catraoine Hydrochloride 10mg Tablets are used for the relief of symptoms of hay fever and other allergic conditions (e.g. sneezing runny or itchy nose) or for skin rashes (chronic nettle rash Idiopathic urticaria) in adults and children over 6 years of age.

2. What you need to know before you take Rhizin

Do not take Rhizin if you are allergic to cetirizine hydrochloride, or any of the ingredients of this medicine to hydroxyzine or to any piperazine derivatives (closely related active substances of other medicines).

If you have a severe kidney disease (severe renal failure with creatinine clearance below 10 miming)

Warnings and precautions

• If you have liver or kidney problems, please ask your doctor for advice, if necessary, you will take a lower dose. The new dose will be determined by your doctor.
• If you have problems passing urine (spinal cord problems or prostate or bladder problems) please ask your doctor for advice.
• If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.
• If you are scheduled for allergy testing, ask your doctor if you should stop taking Cetirizine Hydrochloride Tablets for several days before testing. This medicine may affect your allergy test results.

Children and Rhizin

The use of this medicine is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation.

Other medicines and Rhizin

Please tell your doctor or a pharmacist if you are taking have recently taken or might take any other medicines.

Rhizin with food and drink and alcohol. Food does not affect absorption of Rhizin.

No clinically significant interactions have been observed between alcohol (at the blood level of 0.5 g/t corresponding to one glass of wine) and cetirizine used at the recommended doses. However, there are no data available on the safety when higher doses of cetirizine and alcohol are taken together. Therefore, as it is the case with all antihistamines, it is recommended to avoid taking Rhizin Tablets with alcohol.

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.

Rhizin should be avoided in pregnant women Accidental use of the drug by a pregnant woman should not produce any harmful effects on the fetus. Nevertheless, the medicine should only be administered if necessary and after medical advice Cetirizine passes into breast milk Therefore, you should not take Rhizin if you are breast-feeding unless you have contacted a doctor.

Driving and using machines

Clinical studies have produced no evidence of impaired attention alertness and driving capabilities after taking Rhizin at the recommended dose. You should closely observe your response to the drug after you have taken Rhizin if you are intending to drive, engage in potentially hazardous activities or operate machinery. You should not exceed the recommended dose. Rhizin contain lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Rhizin.

3. How to take Rhizin

Always take this medicine exactly as described in this leaflet or as you doctor, or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The tablets should be swallowed with water.

• Adults, elderly patients and children 12 years and over: 1 tablet daily 
• Child aged 6 to 12 years: Half a tablet twice daily or 5 ml twice daily. 
• Children under 6 years: 2.5ml twice daily or 5ml daily.
• Patients with renal impairment: Patients with moderate renal impairment are recommended to take 5 mg once daily.

 If you have severe kidney problems (or liver and kidney problems together) please contact your doctor or pharmacist who may adjust the dose accordingly.

If your child suffers from kidney disease, please contact your doctor or pharmacist who may adjust the dose according to your child. 

Duration of treatment

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

Caution

• If you take more than you should: If you accidentally take too much medicine, contact your doctor or nurse casualty department at once.
• If you forget to take Rhizin: Do not take a double dose to make up for a forgotten dose.
• If you stop taking Rhizin: Rarely pruritus (intense inching) and/or urticaria may return if you stop taking Rhizin.

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

4. Possible side effects

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

The following side effects are very rare, but you must stop taking the tablets and speak to your doctor immediately if you notice them:

• Allergic reactions including severe reactions and angioedema (serious allergic reaction which causes swelling of the face or throat).
• Convulsions (fits). 
• Thoughts about committing suicide. 
• These reactions may start soon after you first take the medicine, or they might start later. 

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

• Somnolence, sleepiness, dizziness, headache, diarrhea, nausea, dry mouth Fatigue. 
• Pharyngitis, cold-like symptoms of the nose (children only). 

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

• Feeling agitated, Paresthesia (abnormal feelings of the skin). 
• Abdominal pain. Pruritus (itchy skin), rash asthenia (extreme fatigue), malaise (feeling generally unwell). 
• Rare side effects (may affect up to 1 in 1000 patients). 
• Depression, hallucination (hearing or seeing things), aggression, confusion, sleeplessness. 
• Tachycardia (heart beating too fast). 
• Abnormal liver function test results (your doctor will know what to do).
• Urticaria (hives). 
• Oedema (generalized swelling due to water retention) and weight increased.

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

• Low levels of blood platelets causing unusual bleeding or bruising Tics (habit spasm). 
• Syncope, dyskinesia (involuntary movements), dystonia (abnormal prolonged muscular contractions), tremor, dysgeusia (altered taste).
• Blurred vision, accommodation disorder (difficulty focusing), eulogization (eyes having uncontrolled circular movements) 
• Fixed drug eruption. 
• Abnormal elimination of urine (bedwetting, pain and/or difficulty passing water).

Not known frequency of side effects (frequency cannot be estimated from the available data)

• Increased appetite.
• Memory loss and forgetfulness.
• Vertigo (sensation of rotation or movement).
• Urinary retention (inability to completely empty the urinary bladder) Pruritus (intense itching). and/or urticaria upon discontinuation Arthralgia joint pain).
• Acute generalized exanthema Tous pustulosis (rash with blisters containing pus).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects can help provide more information on the safety of this medicine.

5. How to store Rhizin

Store in a cool dry place below 30C protected from light.

Do not use this medicine after the expiry date which is stated on the label/carton/bottle. The expiry date refers to the last day of that month Do not throw away any medicines via wastewater or household waste Ask your pharmacist how to throw away medicines you no longer require. These measures will help protect the environment.

6. Contents of the pack and other information 

What Rhizin Tablets contain

Each tablet contains 10mg of cetirizine dihydrochloride (the active ingredient). They also contain lactose, microcrystalline cellulose, tartrazine, maize starch, povidone, magnesium stearate, purified talc, sodium starch glycollate.

What Rhizin Syrup contain

Each 5ml syrup contains 5mg of cetirizine dihydrochloride the active ingredient)

They also contain Sucrose, citric acid, sodium methyl paraben, sodium citrate.

What Rhizin look like and contents of the pack

The tablets are pale yellow capsule shaped tablet engraved with a break line and on one side.

Tablets Blister pack of 10 x 10 tablets Syrup: 30ml amber colored bottles SHELF LIFE: Tablet Four (4) years. Syrup Three (3) years.

KEEP OUT OF REACH OF CHILDREN

Made in Ghana by KINAPHARMA LIMITED 8920/10, Mausoleum Lane, North Industrial Area, Accra, Ghana.