Solal 5-Htp Capsules 60

A direct precursor for the neurotransmitter serotonin (the feel good hormone). 5-HTP has profound mood-lifting and anti-depressant effects (but without the side effects). Promotes healthy sleep and wake patterns and emotional stability. Assists with migraines, reduces appetite, and alleviates anxiety.

PRODUCT INFORMATION FOR 5-HTP

PROPRIETARY NAME (and dosage form):

5-HTP (capsules)

COMPOSITION: Each capsule contains the following as active ingredients:

5-Hydroxythryptophan 100 mg Vitamin B6 (pyridoxal-5-phosphate) 25 mg

Inactive ingredients:

Hypromellose (cellulose) vegetarian capsule shell (gelatin free), microcrystalline cellulose, magnesium stearate (vegetarian – flow agent), magnesium silicate, silicon dioxide and colloidal silicon dioxide.

PHARMACOLOGICAL CLASSIFICATION:

A.32.16 Others

PHARMACOLOGICAL ACTION:

Tryptophan hydroxylase catalyzes the first rate-limiting step of serotonin biosynthesis by converting L-tryptophan to 5-hydroxytryptophan (5-HTP). 5-HTP is then converted into serotonin. Vitamin B6 is a cofactor for the endogenous conversion of 5-HTP to serotonin via the 5-HTP decarboxylase enzyme. Serotonin controls a variety of functions in the human body and brain. Inadequate serotonin effects also play a major role in depression, and mood disturbances. Serotonin is also converted into melatonin in the pineal gland where it plays a major role in the human sleep cycle.

INDICATIONS:

5-HTP helps to promote healthy mood and is used as a sleep aid. 5-HTP also helps to relieve the symptoms of fibromyalgia which include reducing the number of tender points, anxiety, pain, fatigue and morning stiffness.

CONTRAINDICATIONS:

Avoid in infants with Down’s syndrome due to the potential for spasm. Avoid in individuals suffering from scleroderma. Avoid in individuals with a known allergy to 5-HTP containing products. Signs of allergy to 5-HTP may include rash, itching or shortness of breath.

WARNINGS:

Do not exceed recommended dosages unless on the advice of a health care provider. If you are on any medication or suffering from any medical condition, it is advisable to seek medical advice before starting any new medicine, supplement or remedy.

INTERACTIONS:

Use with extreme caution in individuals taking antidepressant medications (TCAs, MAOIs, SSRIs, nefazodone, trazodone, venlafaxine, mirtazapine, bupropion) due to theoretical increased serotonergic-excess adverse effects.

Use cautiously in individuals taking 5-HTP receptor agonists such as sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, imotriptan, and frovatriptan.

Use cautiously in individuals taking carbidopa, dextromethorphan, meperidine, phenobarbital, pentazocine, pindolol, reserpine, tramadol, or zolpidem.

Use cautiously in individuals with renal insufficiency as 5-HTP is eliminated renally.

Use cautiously in individuals with HIV/AIDS, particularly HIV-1 infection.

Use cautiously in individuals with epilepsy as 5-HTP may inhibit both focal and generalized seizures. Use cautiously in individuals with a history of mental disorders.

Use cautiously in individuals using the following herbs and supplements: Hawaiian baby wood rose, L-tryptophan, S-adenosylmethionine (SAMe), St.John’s wort.

PREGNANCY AND BREASTFEEDING:

There is a current lack of adequate, well-controlled studies on the use of 5-HTP in pregnancy; therefore it should not be used while pregnant. 5-HTP can increase prolactin, a necessary hormone for milk production; 5-HTP should be avoided while breastfeeding.

DOSAGE AND DIRECTIONS FOR USE:

Dosage: Adults aged 18 and older

Depression: Take 1 capsule three times daily, with food. Use for a minimum of 1 week to see beneficial effects.

Fibromyalgia: Take 1 capsule three times daily, with food. Use for a minimum of 2 weeks to see beneficial effects.

Sleep aid: Take 1 to 2 capsules at night 30-45 minutes before bedtime. Individuals using more than 4 capsules per day should consult their health care provider if they intend continuing for more than 12 weeks.

Children (age less than 18): General: There is not enough scientific data to recommend 5-HTP for use in children, and 5-HTP is not usually recommended because of potential side effects.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

Side Effects:

Allergy: Known allergy/hypersensitivity to 5-HTP. Signs of allergy may include rash, itching or shortness of breath.

Adverse Effects/Post Market Surveillance: Body System:Adverse Event Frequency Cardiovascular Palpitations Rare Hypotension Rare Dermatological Urticaria Rare Skin Allergy (rash and itching) Rare Gastrointestinal Gastrointestinal upset Common Nausea Common Diarrhoea Common Heartburn Common Flatulence Common Taste alteration Rare

Note: Slow initiation of treatment has decreased gastrointestinal side effects. Musculoskeletal Myalgia Rare Neurological Drowsiness Uncommon Dizziness Uncommon Vertigo Uncommon Somnolence Uncommon Insomnia Uncommon Headache Uncommon Mania Rare Euphoria Rare Psychiatric Hypomania (Doses >600mg per day)

Common Other: Shortness of breath (allergy), Rare Weight gain, Rare Anorexia ,Rare Amenorrhea, Rare Special Precautions: 5-HTP might interfere with surgical procedures due to serotonergic central nervous effects or serotonergic effects on the vascular system, for this reason usage of 5-HTP should be discontinued 2 weeks prior to elective surgical procedures. 5-HTP should be discontinued if any adverse reactions occur and a physician should be contacted. Some people may experience drowsiness from 5-HTP. Caution should be exercised when operating heavy machinery, driving a motor vehicle or if the patient is involved in activities requiring mental alertness.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

Treatment should be symptomatic and supportive. In the case of accidental overdose of the product, contact the nearest hospital or poison control centre.

IDENTIFICATION:

White clear vegetarian capsule shell (size 0) containing off-white powder. Capsule shell – gelatin free. Contains plant extracts and natural filler, with no colourants added.

PRESENTATION:

White HDPE container with white HDPE screw cap and seal for protection. Containing 60 capsules.

STORAGE INSTRUCTIONS:

Store in a cool dry place below 25 degrees C. Keep out of the reach of children.

Kindly note that we do not give any medical advice. Raines Africa.com is a retail website, selling supplements and other health-related branded products (none of which are scheduled medication). Any medical advice should be given by your personal health care professional.

Disclaimer
DISCLAIMER: This product may be a complementary medicine and/or not have been evaluated and verified by the South African Health Products Regulatory Authority for its quality, safety or intended use. Use of this product is therefore not intended to compensate for diagnosis, treatment, cure, or mitigation of medical conditions and must not substitute the obtaining of medical advice from a registered health professional for any health or health-related conditions.