Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Rozex 0.75% w/w Cream
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Metronidazole may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Your doctor has prescribed this cream 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.
What you need to know before you take it
e Rozex Do not use Rozex are allergic to metronidazole or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include a rash or itching. you are affected by Cockayne syndrome. Cases of severe liver toxicity/acute liver failure, including cases with a fatal outcome, in patients with Cockayne syndrome have been reported with products containing metronidazole. Polysorbates can cause allergic reactions. Warnings and precautions Talk to your doctor or pharmacist before using Rozex. Do not get the cream in your eyes. If you do, rinse thoroughly with large amounts of warm water or eye wash. 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 (eg 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 reduce blood clotting (anticoagulants) such as warfarin and dicoumarin. Contact your doctor for advice if you are taking medicines to reduce blood clotting, 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 Cream because it is only applied on the skin. However, you are advised not to drink alcohol while you are using Rozex Cream. 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 orpharmacist for advice before taking this medicine. Rozex contains cetostearyl alcohol which may cause local skin reactions contact dermatitis). mg of benzyl alcohol (E1519) in each gram which is equivalent to 2.2 it may cause allergic reactions and mild local irritation. –
How to take it
Rozex Always use this medicine exactly as your doctor had told you. Check with your doctor or pharmacist if you are not sure. First wash and dry the affected areas of your skin. Apply a thin layer of the cream to all the affected areas be careful not to get it in your eyes. Rub the cream well in. Always replace the cap and wash your hands after use. Your cream 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. –
P Code: P202264-1 Description: (025037) P202264-1 ROZEX CRE 50 GBR INSERT
SGK
Market: GB Article: Leaflet Designation: TBC
Plan No: DRA.0352.R03
Colours and PANTONE 432 U
Dimensions: 180X315
Print Spec: N/A
Service Order: 404324843 Version No: V3 Date: 27-10-2025 Operator: VS
Pharma code: 29/0
Barcode: N/A
Cutter Ref: DRA.0352.R03 Print Process: N/A
Mag: N/A BWR: N/A
GALDERMA EST.1981
Version No:
ARTWORK
3
NOTICE VERSO 180×315 PLAN n°
If you use more Rozex than you should or accidentally swallow the cream 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 worry if you forget to use your cream at the right time. Although this cream works best if you use it regularly as directed, 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.
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 SKIN 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 (hypothesia) 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) skin irritation should occur either use the cream 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 https://yellowcard.mhra.gov.uk 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. –
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How to store it
Rozex Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the tube and carton. The expiry date refers to the last day of that month.
- Do not store above 25°C. Do not refrigerate. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Rozex contains The active substance is metronidazole. Each gram of Rozex contains 7.5mg of metronidazole. The other ingredients are emulsifying wax (cetostearyl alcohol and polysorbate-60), benzyl alcohol (E1519), isopropyl palmitate, glycerol, sorbitol solution 70% non-crystallising, lactic acid, sodium hydroxide (for pH adjustment) and purified water. What Rozex looks like and contents of the pack tube, only on prescription from your doctor. Rozex is a white to beige is available in a 30 g, 40 g or Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Galderma (U.K.) Limited, Evergreen House North, Grafton Place, London, England, NW1 2DX. Montdésir, 74540, Manufacturer: Laboratoires Galderma, Alby-sur-Chéran, France. This leaflet was last revised in October 2025. –
GALDERMA P Code: P202264-1 Description: (025037) P202264-1 ROZEX CRE 50 GBR INSERT
SGK
Market: GB Article: Leaflet Designation: TBC
Plan No: DRA.0352.R03
Colours and Varnishes: PANTONE 432 U
Dimensions: 180X315
Print Spec: N/A
Service Order: 404324843 Version No: V3 Date: 27-10-2025 Operator: VS
Pharma code: 29/0
Barcode: N/A
Cutter Ref: DRA.0352.R03 Print Process: N/A
Mag: N/A BWR: N/A
GALDERMA EST.1981
Version No:
ARTWORK
3
Frequently asked questions about Rozex 0.75% w/w Cream
How do I take Rozex 0.75% w/w Cream?
Rozex 0.75% w/w Cream comes as cream. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Rozex 0.75% w/w Cream?
The active substance in Rozex 0.75% w/w Cream is metronidazole.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Rozex 0.75% w/w Cream, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Rozex 0.75% w/w Cream without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: metronidazole
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Rozex cream is indicated in the treatment of inflammatory papules, pustules and erythema of rosacea
4.2. Posology and method of administration
Posology
This medicinal product is for topical administration only.
The average period of treatment is three to four months. The recommended duration of treatment should not be exceeded. However, if a clear benefit has been demonstrated, continued therapy for a further three to four months period may be considered by the prescribing physician depending on the severity of the condition. In clinical studies, topical metronidazole therapy for rosacea has been continued for up to 2 years. In the absence of a clear clinical improvement, therapy should be stopped.
Older people: The dosage recommended in the elderly is the same as that recommended in adults.
Paediatric population: Not recommended. Safety and efficacy have not been established.
Method of administration
Rozex Cream should be applied in a thin layer to the affected areas of the skin twice daily, morning and evening. Areas to be treated should be washed with a mild cleanser before application. Patients may use non-comedogenic and non-astringent cosmetics after application of Rozex Cream.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Metronidazole must not be used in patients with Cockayne syndrome. Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation in patients with Cockayne syndrome have been reported with products containing metronidazole for systemic use.
4.4. Special warnings and precautions for use
Contact with mucous membranes should be avoided.
Rozex Cream has been reported to cause lacrimation of the eyes, therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs patients should be directed to use the medication less frequently or discontinue use temporarily and to seek medical advice if necessary. Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of, blood dyscrasia. Exposure of treated sites to ultraviolet (e.g. solarium, sun-lamp) or strong sunlight (including sun-bathing) should be avoided during use of metronidazole. Metronidazole transforms into inactive metabolite due to UV exposure, therefore its efficacy decreases significantly. Phototoxic side-effects haven't been reported in clinical trials in relation to metronidazole. Unnecessary and prolonged use of this medication should be avoided.
Evidence suggests that metronidazole is carcinogenic in certain animal species. There is no evidence to date of a carcinogenic effect in human (see section 5.3).
The excipient cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). This medicine also contains 22mg benzyl alcohol (E1519) in each gram which is equivalent to 2.2%w/w, it may cause allergic reactions and mild local irritation.
This medicinal product also contains Polysorbate 60 which can cause allergic reactions.
4.5. Interaction with other medicinal products and other forms of interaction
Interaction with systemic medication is unlikely because absorption of metronidazole following cutaneous application of Rozex Cream is low. Nevertheless, it should be mentioned that disulfiram-like reactions have been reported in a small number of patients taking metronidazole and alcohol concomitantly. Oral metronidazole has been reported to potentiate the effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin is not known. However, very rare cases of modification of the INR values have been reported with concomitant use of Rozex and coumarin anticoagulants.
4.6. Fertility, pregnancy and lactation
Pregnancy
There is no experience to date with the use of Rozex Cream in pregnancy. In case of oral administration, metronidazole crosses the placental barrier and rapidly enters the foetal circulation. No foetotoxicity was observed after oral metronidazole in either rats or mice. However because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents this drug should be used in pregnancy only if clearly needed.
Breast-feeding
After oral administration, Metronidazole is excreted in breast milk in concentrations similar to those found in the plasma. Even though Metronidazole blood levels from topical administration are significantly lower than those achieved after oral administration, in nursing mothers a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
4.7. Effects on ability to drive and use machines
Rozex Cream has no influence on the ability to drive and use machines.
4.8. Undesirable effects
Because of the minimal absorption of metronidazole and consequently its insignificant plasma concentration after topical administration, the adverse experiences reported with the oral form of the drug have not been reported with Rozex Cream. Adverse reactions reported with Rozex Cream have been only local and mild.
System Organ Class
Frequency
Adverse drug reaction
Skin and subcutaneous tissue disorders
Common ( ≥ 1/100, < 1/10)
Dry skin, erythema, pruritus, skin discomfort (burning, pain of skin/stinging), skin irritation, worsening of rosacea.
Unknown frequency
Contact dermatitis, swelling face, skin exfoliation
Nervous system disorders
Uncommon (≥ 1/ 1,000, < 1/100)
Hypothesia, paraesthesia, dysgeusia (metallic taste)
Gastrointestinal disorders
Uncommon (≥ 1/ 1,000, < 1/100)
Nausea
Watery eyes have been reported if applied too closely to this area.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
No data exists about overdosage in humans. Acute oral toxicity studies with a topical gel formulation containing 0.75% w/w metronidazole in rats have shown no toxic action with doses of up to 5 g of finished product per kilogram body weight, the highest dose used. This dose is equivalent to the oral intake of 12 tubes of 30g packaging Rozex Cream for an adult weighing 72 kg, and 2 tubes of Cream for a child weighing 12 kg.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- METRONIDAZOL NORIDEM 500 mg/100 ml prescriptionMETRONIDAZOLUM · injection / infusion
- METRONIDAZOL BRAUN 5mg/ml prescriptionMETRONIDAZOLUM · injection / infusion
- METRONIDAZOL ARENA 500 mg prescriptionMETRONIDAZOLUM · taken by mouth
- METRONIDAZOL VIOSER 500 mg/100 ml prescriptionMETRONIDAZOLUM · injection / infusion
- METRONIDAZOL ARENA 250 mg (P01AB1) prescriptionMETRONIDAZOLUM · taken by mouth
- METRONIDAZOL A 5 g/l prescriptionMETRONIDAZOLUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- Metronidazol ChemaMetronidazolum · skin / topical
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Rozex 0.75% w/w Cream. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
Medicines containing Metronidazole
- Acea 0.75% w/w Gel
- Metrogel 0.75% w/w Gel
- Metronidazole 200 mg Film-Coated Tablets
- Metronidazole 200mg Tablets
- Metronidazole 400 mg Film-Coated Tablets
- Metronidazole 400 mg Tablets
- Metronidazole 500 mg / 100 ml Intravenous Infusion
- Metronidazole 500 mg film-coated tablets
- Metronidazole 500 mg/100 ml Solution for Infusion
- Rozex 0.75% w/w Gel