Advertisement

SOMNIL TABLETS

Main information

  • Trade name:
  • SOMNIL TABLETS
  • Available from:
  • Sad-otc
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
Advertisement

Documents

Localization

  • Available in:
  • SOMNIL TABLETS
    South Africa
  • Language:
  • English

Other information

Advertisement

Status

  • Source:
  • Sounth African Electronic Package Inserts
  • Last update:
  • 09-08-2016

Patient Information leaflet

Advertisement

SOMNIL TABLETS

SCHEDULING STATUS:

S2

PROPRIETARY NAME

(and dosage form):

SOMNIL TABLETS

COMPOSITION:

Each tablet contains:

Doxylamine Succinate 25,00 mg

PHARMACOLOGICAL CLASSIFICATION:

A 2.2 Sedative, hypnotics,

PHARMACOLOGICAL ACTION:

Doxylamine succinate, a member of the Ethanolamine group of H1 -Blocking Agents, has a pronounced tendency to

induce sedation.

INDICATIONS:

Doxylamine succinate is indicated for the alleviation of insomnia.

CONTRA-INDICATIONS:

Doxylamine succinate should not be taken during pregnancy, nor whilst breastfeeding. It is also contra-indicated in

epileptics, in patients with severe cardio-vascular disorders, and in patients suffering from an acute asthma attack.

WARNINGS:

This medicine leads to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake

of alcohol or other central nervous system depressant agents. Patients should be warned not to take charge of

vehicles, other means of transport or machinery where loss of attention may lead to accidents.

DOSAGE AND DIRECTIONS FOR USE:

One to two tablets with water at bedtime.

Not to be administered to children under the age of 12.

This product should be used occasionally and should not be used successively for periods exceeding several days. If

insomnia persists consult your doctor.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

Side-effects:

The most common side-effect is sedation, varying from slight drowsiness to deep sleep, and including lassitude, dizziness

and in-coordination.

Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation, anorexia or

increased appetite and epigastric pain.

Doxylamine succinate may also produce antimuscarinic effects including blurred vision, difficulty in micturition,

dysuria, dryness of the mouth and tightness of the chest. Other central effects include hypotension, muscular weakness,

tinnitus, euphoria or depression, headache, irritability and nightmares.

Paradoxical central nervous system stimulation may occur with insomnia, nervousness, tachycardia, tremors and

convulsions. Doxylamine succinate may precipitate epileptiform seizures in patients with focal lesions of the cerebral

cortex.

cortex.

Allergic reactions and cross-sensitivity to related medicines may occur.

Blood disorders, including agranulocytosis, leucopenia and haemolytic anemia have been reported.

Special Precautions:

Doxylamine should be used with care in the elderly, and in conditions such as closed-angle glaucoma, urinary retention,

liver impairment, prostatic hypertrophy or pyloroduodenal obstruction.

Use with care in cardiac failure, hypertension, oedema and cardiovascular disease.

Interactions:

Doxylamine succinate may enhance the sedative effects of central nervous system depressants including alcohol,

tricyclic antidepressants, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers.

Mono amine oxidase inhibitors may enhance the antimuscarinic effects of doxylamine succinate, and it has additive

effects with other antimuscarinic agents, such as atropine and tricyclic antidepressants.

It has been suggested that doxylamine succinate could mask the warning signs of damage caused by ototoxic medicines

such as aminoglycoside antibiotics.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

In children CNS stimulation, resulting in ataxia, excitement, tremors, psychoses, hallucinations and convulsions, occurs.

Hyperpyrexia may also occur. Deepening coma and cardiorespiratory collapse may follow. Death may occur from

respiratory failure.

In adults, CNS depression is more common, with drowsiness, coma and convulsions, progressing to respiratory failure or

possibly cardio-vascular collapse.

Treatment is supportive and symptomatic.

IDENTIFICATION:

Pale blue, flat, bisected tablets with bevelled edges having a diameter of 7 mm.

PRESENTATION:

Packs of 12 and 24 tablets.

STORAGE INSTRUCTIONS:

Store below 25 °C.

Protect from light and moisture.

KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:

Q/2.2/186

NAME AND BUSINESS ADDRESS OF APPLICANT:

S.A.D. SELF MEDICATION [PTY] LIMITED

Co. Reg. No. 92/04769/07

Robbie de Lange Road, Wilsonia, EAST LONDON, 5201

P O Box 422, EAST LONDON, 5200

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

11 April 1985

30-8-2016

Ton Shen Health/Life Rising Expands Recalls of “DHZC-2 Tablet” to All Lots Purchased Before August 24 2016 Because of Possible Health Risk

Ton Shen Health/Life Rising Expands Recalls of “DHZC-2 Tablet” to All Lots Purchased Before August 24 2016 Because of Possible Health Risk

Ton Shen Health/Life Rising Corporation of Chicago, IL, is expanding its recall of DHZC-2 Tablets to all lots purchased before August 24, 2016 because they have the potential to be contaminated with elevated levels of lead.

FDA - U.S. Food and Drug Administration

29-8-2016

Dietary Supplements by Ton Shen Health/Life Rising: Recall - Elevated Lead Levels

Dietary Supplements by Ton Shen Health/Life Rising: Recall - Elevated Lead Levels

Recall expanded to include all lots of DHZC-2 tablets. Distribution of all Life Rising products on hold until September 1, 2016.

FDA - U.S. Food and Drug Administration

18-8-2016

Cetylev (acetylcysteine) Effervescent Tablets for Oral Solution by Arbor Pharmaceuticals: Recall - Inadequate Seal of Blister Pack

Cetylev (acetylcysteine) Effervescent Tablets for Oral Solution by Arbor Pharmaceuticals: Recall - Inadequate Seal of Blister Pack

Risk of sub-therapeutic dose as well as potential microbial contamination.

FDA - U.S. Food and Drug Administration

18-8-2016

Voluntary Nationwide Recall of Cetylev® (Acetylcysteine) Effervescent Tablets for Oral Solution Due to an Inadequate Seal of the Blister Pack

Voluntary Nationwide Recall of Cetylev® (Acetylcysteine) Effervescent Tablets for Oral Solution Due to an Inadequate Seal of the Blister Pack

Arbor Pharmaceuticals, LLC (Arbor) today announced a voluntary recall of three (3) lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, due to an inadequate seal of the blister pack. An inadequate seal could result in an increase of oxygen and moisture entering the blister cavity which can start the effervescent process. This results in enlarged and swelled tablets which could also completely dissolve within the blister pack.

FDA - U.S. Food and Drug Administration

12-8-2016

DHZC-2 Tablet by Ton Shen Health: Recall - Possible Health Risk

DHZC-2 Tablet by Ton Shen Health: Recall - Possible Health Risk

Tablets have the potential to be contaminated with elevated levels of lead, a naturally occurring element which can affect multiple body system and particularly harmful to young children.

FDA - U.S. Food and Drug Administration

12-8-2016

Ton Shen Health Recalls “DHZC-2 Tablet” Because of Possible Health Risk

Ton Shen Health Recalls “DHZC-2 Tablet” Because of Possible Health Risk

Ton Shen Health of Chicago, IL, is recalling its “DHZC-2” Tablets because they have the potential to be contaminated with elevated levels of lead, a naturally occurring element which can affect multiple body system and particularly harmful to young children. Lead poisoning can happen if a person is exposed to high levels of lead over short period of time.

FDA - U.S. Food and Drug Administration

28-7-2016

Foreign Product Alert: DR's Secret Bio Herbs Coffee, Exhilarate, Ultimate Nutrition Amino Gold (1000mg capsules, 1000mg tablets, 1500mg tablets), Michael's Naturopathic Programs Cholesterol Metabolism Factors

Foreign Product Alert: DR's Secret Bio Herbs Coffee, Exhilarate, Ultimate Nutrition Amino Gold (1000mg capsules, 1000mg tablets, 1500mg tablets), Michael's Naturopathic Programs Cholesterol Metabolism Factors

These foreign health products have been found by regulators in other countries to contain undeclared allergens and or undeclared drug ingredients.

Canada - Health Canada

13-7-2016

Foreign Product Alert: 3rd Degree, Black Gold X Advanced, The Body Shot Bar Step 2, Black Label X, Super Dragon capsules, Lang Yi Hao Tablets, Hai Leng Hai Beh Herbal Itch Removing Capsule

Foreign Product Alert: 3rd Degree, Black Gold X Advanced, The Body Shot Bar Step 2, Black Label X, Super Dragon capsules, Lang Yi Hao Tablets, Hai Leng Hai Beh Herbal Itch Removing Capsule

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients.

Canada - Health Canada

14-6-2016

Foreign Product Alert: Excellence Losing Weight capsules, Meizitang Botanical Slimming 100% Natural Soft Gel, Natural Model capsules, Boss Number #Six, Bull, Bull's Genital, Ginseng Power-X, Golden Night, Half Quite tablets, Maxagra capsules, Neophase Nat

Foreign Product Alert: Excellence Losing Weight capsules, Meizitang Botanical Slimming 100% Natural Soft Gel, Natural Model capsules, Boss Number #Six, Bull, Bull's Genital, Ginseng Power-X, Golden Night, Half Quite tablets, Maxagra capsules, Neophase Nat

Unauthorized foreign health products Product Name(s) Hazard(s) Identified Source of Alert Other product information, if available Images Unauthorized Weight Loss Products Excellence Losing Weight capsules Undeclared sibutramine Australian Therapeutic Goods Administration Meizitang Botanical Slimming 100% Natural Soft Gel Undeclared diclofenac Singapore Health S...

Canada - Health Canada

22-8-2016

Acetaminophen Overdose Antidote Cetylev Recalled

Acetaminophen Overdose Antidote Cetylev Recalled

Arbor Pharmaceuticals has recalled three lots of acetylcysteine (Cetylev) effervescent tablets for oral solution (500 mg) because of an inadequate seal of the blister pack, the US Food and Drug Administration (FDA) said today in a safety alert.

US - RxList

1-8-2016

Scientific guideline:  Draft abiraterone tablets 250 mg product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft abiraterone tablets 250 mg product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of abiraterone.

Europe - EMA - European Medicines Agency

1-8-2016

Scientific guideline:  Draft vandetanib film-coated tablets 100 and 300 mg product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft vandetanib film-coated tablets 100 and 300 mg product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of vandetanib.

Europe - EMA - European Medicines Agency

1-8-2016

Scientific guideline:  Draft vemurafenib film-coated tablets 240 mg product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft vemurafenib film-coated tablets 240 mg product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of vemurafenib.

Europe - EMA - European Medicines Agency

12-7-2016

MIRACLE GYN (2 TABLETS) (Allantoin) Tablet [Haudongchun Co., Ltd.]

MIRACLE GYN (2 TABLETS) (Allantoin) Tablet [Haudongchun Co., Ltd.]

Updated Date: Jul 12, 2016 EST

US - DailyMed

12-7-2016

MIRACLE GYN (10 TABLETS) (Allantoin) Tablet [Haudongchun Co., Ltd.]

MIRACLE GYN (10 TABLETS) (Allantoin) Tablet [Haudongchun Co., Ltd.]

Updated Date: Jul 12, 2016 EST

US - DailyMed

12-7-2016

JILGYUNGYI (20 TABLETS) (Allantoin) Tablet [Haudongchun Co., Ltd.]

JILGYUNGYI (20 TABLETS) (Allantoin) Tablet [Haudongchun Co., Ltd.]

Updated Date: Jul 12, 2016 EST

US - DailyMed

8-7-2016

PRAC to Review Risks of Modified-Release Paracetamol

PRAC to Review Risks of Modified-Release Paracetamol

The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.

US - RxList

24-6-2016

News and press releases:  EMA warns that Noxafil tablets and oral suspension have different doses and are not interchangeable

News and press releases: EMA warns that Noxafil tablets and oral suspension have different doses and are not interchangeable

Prescriptions should indicate which dose form is intended

Europe - EMA - European Medicines Agency

11-6-2016

Parents Often Using TVs, Tablets as 'Electronic Babysitters'

Parents Often Using TVs, Tablets as 'Electronic Babysitters'

Title: Parents Often Using TVs, Tablets as 'Electronic Babysitters'Category: Health NewsCreated: 6/10/2016 12:00:00 AMLast Editorial Review: 6/10/2016 12:00:00 AM

US - MedicineNet

6-6-2016

CARBIDOPA TABLETS, 25 MG (Carbidopa Tablets, 25 Mg) Tablet [AvKARE, Inc.]

CARBIDOPA TABLETS, 25 MG (Carbidopa Tablets, 25 Mg) Tablet [AvKARE, Inc.]

Updated Date: Jun 6, 2016 EST

US - DailyMed

Other products with the same active ingredient

Advertisement