SYNALAR RECTAL SIMPLE 0.1 mg/g RECTAL CREAM

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

The active ingredient is fluocinolone acetonide. Synalar rectal simple belongs to a group of medications known as topical agents (external use) for the treatment of hemorrhoids, corticosteroids, which act by reducing anal-rectal inflammation and associated anal itching.

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

2. What you need to know before starting to use Synalar rectal simple

Do not use Synalar rectal simple:

• if you are allergic to fluocinolone acetonide or any of the other components of this medication (listed in section 6).
• if you have a hemorrhoidal hemorrhage (bleeding hemorrhoids).
• if you have an infection in the area to be treated by bacteria, viruses (e.g., herpes) or fungi.

Warnings and precautions

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

• The elderly and debilitated patients in the acute phase should be especially cautious, as they may be more sensitive to the toxic effects of this medication.
• Prolonged use, in occlusive dressing (with materials that do not allow air circulation in the area) or with diapers, of topical corticosteroids can produce atrophy of the skin, mucous membranes, and subcutaneous tissue.
• Prolonged or excessive use can cause the appearance of systemic effects (those that occur when the medication is absorbed and reaches the bloodstream).
• If you have an infection in the area to be treated, it should be treated separately. If there is no rapid improvement, you should discontinue treatment with Synalar rectal simple until the infection is controlled. The use of corticosteroids can potentiate skin infections.
• Patients with severely damaged mucosa and/or infection in the application area should be especially cautious.
• If the product causes irritation, you should discontinue its application.
• Avoid contact with the eyes or around them and mucous membranes.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Use in athletes

Athletes are warned that this medication contains a component, fluocinolone, which can produce a positive result in doping tests.

Children and adolescents

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

No data are available.

Other medications and Synalar rectal simple

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

You should not apply other preparations to the treated area along with Synalar rectal simple.

Pregnancy, breastfeeding, and fertility

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

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

Similarly, caution is advised if you need to use this medication while breastfeeding your baby.

Driving and using machines

Synalar rectal simple does not affect the ability to drive and/or use machines.

Synalar rectal simple contains cetyl alcohol, stearic alcohol, methylparaben (E218), propylparaben (E216), and propylene glycol (E1520)

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

It may cause allergic reactions (possibly delayed) because it contains methylparaben E218 and propylparaben E216.

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

3. How to use Synalar rectal simple

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

Adults

Apply the cream 1 or 2 times a day, after bowel movements.

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

If you have internal hemorrhoids and need to apply the cream inside the rectum, screw the cannula that comes with the package onto the tube and insert the tip into the anus. Then, apply a small amount of cream by exerting gentle pressure on the tube.

If you use more Synalar rectal simple than you should

Using too much Synalar rectal simple could cause adrenal suppression (a disorder that alters the normal production of hormones produced in glands located near the kidneys), with symptoms such as obesity in the trunk, rounded face, accumulation of fat in the cervical area, delayed healing, etc.); other symptoms may include cataracts. In this case, treatment should be discontinued, and your doctor should monitor your adrenal hormonal function.

Accidental ingestion may cause rapid heart rate (tachycardia) and occasional elevations in blood pressure, which subside without the need for medical treatment.

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

If you forget to use Synalar rectal simple

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

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Possible side 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 available data

Rare side effects

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

Very rare side effects

• Adrenal suppression, which alters the normal production of hormones produced in glands located near the kidneys (see section 3 "If you use more Synalar rectal simple than you should").

Side effects of unknown frequency

• Hypersensitivity (allergic reactions)
• Itching (pruritus)
• Skin dryness
• Skin maceration
• Secondary infection
• Blurred vision

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Synalar rectal simple

Keep this medication out of sight and reach of children.

Store below 25°C.

Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Synalar rectal simple

• The active ingredient is fluocinolone acetonide. Each gram of cream contains 0.1 mg of fluocinolone acetonide (0.01%).
• The other components are: cetyl alcohol, stearic 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 package contents

Synalar rectal simple is a rectal cream, white in color. It is available in tubes of 30 and 60 grams. The package comes with a cannula for intrarectal application 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

You can request more information about this medication from the local representative of the marketing authorization holder:

Tora Laboratories, S.L.U.

Avenida de Oporto, 60

28019 Madrid

Spain

Date of the last revision of this leaflet:December 2018.

Detailed information about this medication 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/