ROZEX 0.75% GEL - patient leaflet, side effects, dosage

Rozex® 0.75% Gel

(metronidazole)

Your medicine is available using the name Rozex 0.75% Gel but will be referred to as Rozex throughout this leaflet.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• ■ Keep this leaflet. You may need to read it again.

• ■ If you have any further questions, ask your doctor or pharmacist.

• ■ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• ■ If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Rozex is and what it is used for

• 2. What you need to know before you use Rozex

• 3. How to use Rozex

• 4. Possible side effects

• 5. How to store Rozex

• 6. Contents of the pack and other information

1. what rozex is and what it is used for

• ■ Your doctor has prescribed this gel for your skin condition, rosacea.

• ■ It helps to treat the pimples, pustules (spots) and redness found with this condition.

• ■ Rozex contains the active substance metronidazole. Metronidazole belongs to a group of medicines called antiprotozoal and antibacterial agents and has been shown to help to control infection and inflammation in certain skin problems, such as rosacea.

2. what you need to know before you use rozex

Do not use Rozex

• ■ If you are allergic to metronidazole or any of the other ingredients of this medicine (see section 6 for other ingredients). An allergic reaction may include a rash or itching.

Warnings and precautions

Talk to your doctor or pharmacist before using Rozex.

• ■ Do not get the gel in your eyes. If you do so, rinse thoroughly with large amounts of warm water or eye wash.

• ■ If you suffer from any blood disorders do not use Rozex unless your doctor says you can.

• ■ This product should not be used in children.

• ■ Do not go out into strong sunlight (including sun-bathing) and avoid exposure to ultra-violet light (e.g. solariums, sun-lamps) while you are using this product.

• ■ Avoid prolonged and unnecessary use of this medicine.

Other medicines and Rozex

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• ■ Using Rozex could interfere with drugs used to thin the blood (anticoagulants) such as warfarin and dicoumarin. Contact your doctor for advice if you are taking medicines to thin your blood, or if you suffer from any other blood disorders.

Rozex with alcohol

Metronidazole taken by mouth can react with alcohol. This reaction is unlikely with Rozex Gel because it is only applied on the skin. However, you are advised not to drink alcohol while you are using Rozex Gel.

Pregnancy and breast-feeding

• ■ If you are pregnant or breast-feeding, it may not be advisable to use this product, unless your doctor considers it essential.

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

Rozex Gel contains:

• ■ methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216) which may cause allergic reactions (possibly delayed),

• ■ 30mg propylene glycol in each gram which is equivalent to 3% w/w, it may cause skin irritation.

3. how to use rozex

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults and the elderly

• ■ First wash and dry the affected areas of your skin.

• ■ Apply a thin layer of the gel to all the affected areas -be careful also not to get it in your eyes.

• ■ Rub the gel in well.

• ■ Always replace the cap and wash your hands after use.

• ■ Your gel should be used in this way twice a day, (morning and evening), or as advised by your doctor.

• ■ Your doctor will decide how long you need to use Rozex to keep your rosacea under control.

If you use more Rozex than you should or accidentally swallow the gel

• ■ This product is for use on the skin only. Do not swallow it. If you accidentally do so, seek medical advice.

If you forget to use Rozex

• ■ Although this gel works best if you use it regularly as directed, don’t worry if you forget to use your gel at the right time. When you do remember, start using it again in the same way as before.

If you stop taking Rozex

Rosacea may respond slowly to antibiotics. It is important that you continue using Rozex until your doctor tells you to stop.

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.

Common: may affect up to 1 in 10 people

• ■ dry skin

• ■ redness of the skin (erythema)

• ■ itching of the skin (pruritus)

• ■ skin discomfort (burning, pain of skin/stinging)

• ■ skin irritation

• ■ worsening of rosacea

Uncommon: may affect up to 1 in 100 people

• ■ numbness (hypoesthesia) and tingling (paraesthesia) in the fingers or toes

• ■ metallic taste (dysgeusia)

• ■ feeling sick (nausea)

Not known: frequency cannot be estimated from the available data

• ■ contact dermatitis

• ■ swelling of the face

• ■ peeling skin (exfoliation)

If skin irritation should occur either use the gel a little less often or even stop using it until the irritation settles down. Seek medical advice from your doctor or pharmacist if necessary.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store rozex

• ■ Do not store above 25°C.

• ■ Do not freeze and keep away from direct heat.

• ■ KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

• ■ Do not use Rozex after the ‚Expiry date‘ shown on the tube and carton label. The expiry date refers to the last day of that month.

• ■ If your medicine appears discoloured, or shows any other signs of deterioration, take it back to your pharmacist who will advise you.

• ■ If your doctor decides to stop the treatment, return any leftover tablets to the pharmacist. Only keep them if your doctor tells you to.

• ■ Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. contents of the pack and other information

What Rozex contains

Rozex contains the active ingredient metronidazole.

One gram of gel contains 7.5mg metronidazole.

Also contains the inactive ingredients: carbopol 980, disodium edetate, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), propylene glycol, sodium hydroxide and purified water.

What Rozex looks like and contents of the pack

Rozex is a clear to pale yellow gel which may turn to slightly brown colour over time, which is available in a 30g tube, only on prescription from your doctor.

Manufacturer

Manufactured by:

Laboratoires Galderma Z.I., Alby-sur-Cheran, France.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.

PL No: 08929/0195 | POM |

Leaflet revision and issue date (Ref): 02.11.21

Rozex®is a registered trademark of Nestle Skin Health S.A.

Blind or partially sighted?

Is this leaflet hard to see or read?

Call 01302 365000

(Regulatory)

Please be ready to give the following information: Product name:

Rozex 0.75% Gel

Reference No: 08929/0195

Page 2 of 2