Synalar Rectal Simple 0.1 mg/g rectal cream

Patient Information Leaflet

Introduction

Patient Information Leaflet

Synalar Rectal Simple 0.1 mg/g Rectal Cream

Fluocinolone acetonide

Read the entire package leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What Synalar rectal simple is and what it is used for
2. What you need to know before using Synalar rectal simple
3. How to use Synalar rectal simple
4. Possible adverse effects
5. How to store Synalar rectal simple
6. Contents of the pack and other information

1. What Synalar rectal simple is and what it is used for

The active substance is fluocinolone acetonide. Synalar rectal simple belongs to a group of medicines known as topical agents (for external use) for the treatment of haemorrhoids, corticosteroids, which work by reducing anorectal inflammation and anal itching associated with haemorrhoids.

Synalar rectal simple is indicated for the local symptomatic treatment of anorectal inflammation and anal itching (pruritus) associated with haemorrhoids in adults.

2. What you need to know before using Synalar rectal simple

Do not use Synalar rectal simple:

• if you are allergic to fluocinolone acetonide or to any of the other ingredients of this medicine (listed in section 6).
• if you have haemorrhoidal bleeding (bleeding haemorrhoids).
• if you have an infection in the area to be treated caused by bacteria, viruses (e.g., herpes), or fungi.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Synalar rectal simple.

• Elderly patients and those with acute debilitating illnesses should exercise special caution, as they may be more sensitive to the toxic effects of this medicine.
• Prolonged use, occlusive treatment (using materials that prevent air circulation over the area), or use under diapers of topical corticosteroids may cause atrophy of the skin, mucous membranes, and subcutaneous tissue.
• Prolonged use or use in large amounts may lead to systemic effects (those occurring when the medicine is absorbed into the bloodstream).
• If you have an infection in the area to be treated, it should be treated separately. If rapid improvement does not occur, treatment with Synalar rectal simple should be discontinued until the infection is under control. The use of corticosteroids may worsen skin infections.
• Patients with severely damaged mucosa and/or infection in the application area should exercise special caution.
• If the product causes irritation, you must stop applying it.
• Avoid contact with the eyes or the area around them and other mucous membranes.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Use in athletes

Athletes are advised that this medicine contains a component, fluocinolone, which may result in a positive outcome in doping control tests.

Children and adolescents

The safety and efficacy of Synalar rectal simple have not been established in children and adolescents.

No data are available.

Other medicines and Synalar rectal simple

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

You should not apply other topical preparations to the treated area while using Synalar rectal simple.

Pregnancy, breast-feeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not use Synalar rectal simple for prolonged periods if you are pregnant. Its use should be reserved for cases where the therapeutic benefit outweighs the potential risk.

Similarly, caution is advised if this medicine needs to be used while breastfeeding.

Driving and using machines

Synalar rectal simple has no effect on the ability to drive and/or operate machinery.

Synalar rectal simple contains cetyl alcohol, stearyl alcohol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), and propylene glycol (E1520)

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and stearyl alcohol.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).

This medicine contains 150 mg of propylene glycol in each gram of cream.

3. How to use Synalar simple rectal

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults

Apply the cream 1 or 2 times daily, after bowel movement.

Before applying Synalar simple rectal, carefully clean the affected area, dry it, and apply an amount of cream equivalent to 2 cm to the anal and/or rectal area using a clean gauze pad.

If you have internal hemorrhoids and the cream needs to be applied inside the rectum, screw the applicator nozzle provided with the package onto the tube and insert the tip into the anus. Then, apply a small amount of cream by gently squeezing the tube.

If you use more Synalar simple rectal than you should

Using too much Synalar simple rectal could cause adrenal suppression (a disorder leading to disruption of the normal hormone production by glands located near the kidneys), with symptoms such as trunk obesity, rounded face, fat accumulation in the cervical area, delayed wound healing, etc.; other symptoms may include cataracts. In such cases, treatment should be discontinued and your doctor must monitor your adrenal hormonal axis function.

Accidental ingestion may cause episodes of increased heart rate (tachycardia) and occasional elevations in blood pressure, which resolve without requiring medical treatment.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, call the Toxicology Information Service at 91 562 04 20, or go to a medical center, indicating the medicine and the amount used.

If you forget to use Synalar simple rectal

Do not use a double dose to make up for missed doses.

If you forget to apply Synalar simple rectal at the scheduled time, do so as soon as you remember, and then continue as before.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The possible adverse effects are listed according to the following categories:

• Rare: may affect up to 1 in 1,000 people
• Very rare: may affect up to 1 in 10,000 people
• Frequency not known: cannot be estimated from the available data

Rare adverse effects

• Cutaneous atrophy with thinning of the epidermis (often irreversible)
• Dilation of small blood vessels on the skin surface (telangiectasia)
• Appearance of red patches and spots on the skin (purpura)
• Stretch marks on the skin (striae)
• Acne-like skin eruptions
• Perioral dermatitis (small red papules around the mouth)
• Loss of skin pigmentation (depigmentation)
• Skin rashes (dermatitis and eczema, including contact dermatitis)
• Burning sensation
• Rebound effect

Very rare adverse effects

• Adrenal suppression, leading to disruption of normal hormone production by glands located near the kidneys (see section 3, "If you use more Synalar rectal simple than you should").

Adverse effects of unknown frequency

• Hypersensitivity (allergic reactions)
• Pruritus (itching)
• Dry skin
• Skin maceration
• Secondary infection
• Blurred vision

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Synalar rectal simple

Keep this medicine out of the sight and reach of children.

Store below 25ºC.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Synalar simple rectal

• The active substance is fluocinolone acetonide. Each gram of cream contains 0.1 mg of fluocinolone acetonide (0.01%).
• The other components are: cetyl alcohol, stearyl alcohol, sorbitan stearate, polysorbate 60 (E435), liquid paraffin, methylparaben (E218), propylparaben (E216), propylene glycol (E1520), anhydrous citric acid (E330) and purified water.

Appearance of the product and contents of the container

Synalar simple rectal is a white rectal cream. It is available in tubes of 30 and 60 grams. The package includes a cannula for intrarectal administration when required.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Karo Pharma AB

Box 16184

103 24 Stockholm

Sweden

Manufacturer

Temmler Italia S.R.L.

Via delle Industrie, 2

280061 Carugate, Milan

Italy

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Tora Laboratories, S.L.U.

Avenida de Oporto, 60

28019 Madrid

Spain

Date of the most recent revision of this leaflet: December 2018.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/. http://www.aemps.gob.es/